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INTRON A
Overview
What is INTRON A?
INTRON A (Interferon alfa-2b) for intramuscular, subcutaneous, intralesional, or intravenous Injection is a purified sterile recombinant interferon product.
INTRON A recombinant for Injection has been classified as an alpha interferon and is a water-soluble protein with a molecular weight of 19,271 daltons produced by recombinant DNA techniques. It is obtained from the bacterial fermentation of a strain of bearing a genetically engineered plasmid containing an interferon alfa-2b gene from human leukocytes. The fermentation is carried out in a defined nutrient medium containing the antibiotic tetracycline hydrochloride at a concentration of 5 to 10 mg/L; the presence of this antibiotic is not detectable in the final product. The specific activity of interferon alfa-2b, recombinant is approximately 2.6 × 10 IU/mg protein as measured by the HPLC assay.
Prior to administration, the INTRON A Powder for Injection is to be reconstituted with the provided Diluent for INTRON A (Sterile Water for Injection USP) (see ). INTRON A Powder for Injection is a white to cream-colored powder.
These packages do not require reconstitution prior to administration (see ). INTRON A Solution for Injection is a clear, colorless solution.
What does INTRON A look like?
What are the available doses of INTRON A?
Sorry No records found.
What should I talk to my health care provider before I take INTRON A?
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How should I use INTRON A?
INTRON A is indicated for the treatment of patients 18 years of age or older with hairy cell leukemia.
Not all dosage forms and strengths are appropriate for some indications.
To enhance the tolerability of INTRON A, injections should be administered in the evening when possible.
To reduce the incidence of certain adverse reactions, acetaminophen may be administered at the time of injection.
The solution should be allowed to come to room temperature before using.
What interacts with INTRON A?
- INTRON A is contraindicated in patients with:
- INTRON A and REBETOL combination therapy is additionally contraindicated in:
- See REBETOL prescribing information for additional information.
What are the warnings of INTRON A?
General
Moderate to severe adverse experiences may require modification of the patient's dosage regimen, or in some cases termination of INTRON A therapy. Because of the fever and other "flu-like" symptoms associated with INTRON A administration, it should be used cautiously in patients with debilitating medical conditions, such as those with a history of pulmonary disease (e.g., chronic obstructive pulmonary disease) or diabetes mellitus prone to ketoacidosis. Caution should also be observed in patients with coagulation disorders (e.g., thrombophlebitis, pulmonary embolism) or severe myelosuppression.
Cardiovascular Disorders
INTRON A therapy should be used cautiously in patients with a history of cardiovascular disease. Those patients with a history of myocardial infarction and/or previous or current arrhythmic disorder who require INTRON A therapy should be closely monitored (see ). Cardiovascular adverse experiences, which include hypotension, arrhythmia, or tachycardia of 150 beats per minute or greater, and rarely, cardiomyopathy and myocardial infarction have been observed in some INTRON A-treated patients. Some patients with these adverse events had no history of cardiovascular disease. Transient cardiomyopathy was reported in approximately 2% of the AIDS-Related Kaposi's Sarcoma patients treated with INTRON A. Hypotension may occur during INTRON A administration, or up to 2 days post-therapy, and may require supportive therapy including fluid replacement to maintain intravascular volume.
Supraventricular arrhythmias occurred rarely and appeared to be correlated with preexisting conditions and prior therapy with cardiotoxic agents. These adverse experiences were controlled by modifying the dose or discontinuing treatment, but may require specific additional therapy.
Cerebrovascular Disorders
Ischemic and hemorrhagic cerebrovascular events have been observed in patients treated with interferon alpha-based therapies, including INTRON A. Events occurred in patients with few or no reported risk factors for stroke, including patients less than 45 years of age. Because these are spontaneous reports, estimates of frequency cannot be made and a causal relationship between interferon alpha-based therapies and these events is difficult to establish.
Neuropsychiatric Disorders
DEPRESSION AND SUICIDAL BEHAVIOR INCLUDING SUICIDAL IDEATION, SUICIDAL ATTEMPTS, AND COMPLETED SUICIDES, HOMICIDAL IDEATION, AND AGGRESSIVE BEHAVIOR SOMETIMES DIRECTED TOWARDS OTHERS, HAVE BEEN REPORTED IN ASSOCIATION WITH TREATMENT WITH ALPHA INTERFERONS, INCLUDING INTRON A THERAPY. If patients develop psychiatric problems, including clinical depression, it is recommended that the patients be carefully monitored during treatment and in the 6-month follow-up period.
INTRON A should be used with caution in patients with a history of psychiatric disorders. INTRON A therapy should be discontinued for any patient developing severe psychiatric disorder during treatment. Obtundation and coma have also been observed in some patients, usually elderly, treated at higher doses. While these effects are usually rapidly reversible upon discontinuation of therapy, full resolution of symptoms has taken up to 3 weeks in a few severe episodes. If psychiatric symptoms persist or worsen, or suicidal or homicidal ideation or aggressive behavior towards others is identified, discontinue treatment with INTRON A and follow the patient closely, with psychiatric intervention as appropriate. Narcotics, hypnotics, or sedatives may be used concurrently with caution and patients should be closely monitored until the adverse effects have resolved. Suicidal ideation or attempts occurred more frequently among pediatric patients, primarily adolescents, compared to adult patients (2.4% versus 1%) during treatment and off-therapy follow-up. Cases of encephalopathy have also been observed in some patients, usually elderly, treated with higher doses of INTRON A.
Treatment with interferons may be associated with exacerbated symptoms of psychiatric disorders in patients with co-occurring psychiatric and substance use disorders. If treatment with interferons is initiated in patients with prior history or existence of psychiatric condition or with a history of substance use disorders, treatment considerations should include the need for drug screening and periodic health evaluation, including psychiatric symptom monitoring. Early intervention for re-emergence or development of neuropsychiatric symptoms and substance use is recommended.
Bone Marrow Toxicity
INTRON A therapy suppresses bone marrow function and may result in severe cytopenias including aplastic anemia. It is advised that complete blood counts (CBC) be obtained pretreatment and monitored routinely during therapy (see ). INTRON A therapy should be discontinued in patients who develop severe decreases in neutrophil (less than 0.5 × 10/L) or platelet counts (less than 25 × 10/L) (see ).
Ophthalmologic Disorders
Decrease or loss of vision, retinopathy including macular edema, retinal artery or vein thrombosis, retinal hemorrhages and cotton wool spots; optic neuritis, papilledema, and serous retinal detachment may be induced or aggravated by treatment with interferon alfa-2b or other alpha interferons. All patients should receive an eye examination at baseline. Patients with preexisting ophthalmologic disorders (e.g., diabetic or hypertensive retinopathy) should receive periodic ophthalmologic exams during interferon alpha treatment. Any patient who develops ocular symptoms should receive a prompt and complete eye examination. Interferon alfa-2b treatment should be discontinued in patients who develop new or worsening ophthalmologic disorders.
Endocrine Disorders
Infrequently, patients receiving INTRON A therapy developed thyroid abnormalities, either hypothyroid or hyperthyroid. The mechanism by which INTRON A may alter thyroid status is unknown. Patients with preexisting thyroid abnormalities whose thyroid function cannot be maintained in the normal range by medication should not be treated with INTRON A. Prior to initiation of INTRON A therapy, serum TSH should be evaluated. Patients developing symptoms consistent with possible thyroid dysfunction during the course of INTRON A therapy should have their thyroid function evaluated and appropriate treatment instituted. Therapy should be discontinued for patients developing thyroid abnormalities during treatment whose thyroid function cannot be normalized by medication. Discontinuation of INTRON A therapy has not always reversed thyroid dysfunction occurring during treatment. Diabetes mellitus has been observed in patients treated with alpha interferons. Patients with these conditions who cannot be effectively treated by medication should not begin INTRON A therapy. Patients who develop these conditions during treatment and cannot be controlled with medication should not continue INTRON A therapy.
Gastrointestinal Disorders
Hepatotoxicity, including fatality, has been observed in interferon alpha-treated patients, including those treated with INTRON A. INTRON A increases the risk of hepatic decompensation and death in patients with cirrhosis. Any patient developing liver function abnormalities during treatment should be monitored closely and if appropriate, treatment should be discontinued.
Pulmonary Disorders
Dyspnea, pulmonary infiltrates, pneumonia, bronchiolitis obliterans, interstitial pneumonitis, pulmonary hypertension, and sarcoidosis, some resulting in respiratory failure and/or patient deaths, may be induced or aggravated by INTRON A or other alpha interferons. Recurrence of respiratory failure has been observed with interferon rechallenge. The etiologic explanation for these pulmonary findings has yet to be established. Any patient developing fever, cough, dyspnea, or other respiratory symptoms should have a chest X-ray taken. If the chest X-ray shows pulmonary infiltrates or there is evidence of pulmonary function impairment, the patient should be closely monitored, and, if appropriate, interferon alpha treatment should be discontinued. While this has been reported more often in patients with chronic hepatitis C treated with interferon alpha, it has also been reported in patients with oncologic diseases treated with interferon alpha.
Autoimmune Disorders
Rare cases of autoimmune diseases including thrombocytopenia, vasculitis, Raynaud's phenomenon, rheumatoid arthritis, lupus erythematosus, and rhabdomyolysis have been observed in patients treated with alpha interferons, including patients treated with INTRON A. In very rare cases the event resulted in fatality. The mechanism by which these events developed and their relationship to interferon alpha therapy is not clear. Any patient developing an autoimmune disorder during treatment should be closely monitored and, if appropriate, treatment should be discontinued.
Human Albumin
The powder formulations of this product contain albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for albumin.
AIDS-Related Kaposi's Sarcoma
INTRON A therapy should not be used for patients with rapidly progressive visceral disease (see ). Also of note, there may be synergistic adverse effects between INTRON A and zidovudine. Patients receiving concomitant zidovudine have had a higher incidence of neutropenia than that expected with zidovudine alone. Careful monitoring of the WBC count is indicated in all patients who are myelosuppressed and in all patients receiving other myelosuppressive medications. The effects of INTRON A when combined with other drugs used in the treatment of AIDS-related disease are unknown.
Chronic Hepatitis C and Chronic Hepatitis B
Patients with decompensated liver disease, autoimmune hepatitis or a history of autoimmune disease, and patients who are immunosuppressed transplant recipients should not be treated with INTRON A. There are reports of worsening liver disease, including jaundice, hepatic encephalopathy, hepatic failure, and death following INTRON A therapy in such patients. Therapy should be discontinued for any patient developing signs and symptoms of liver failure.
Chronic hepatitis B patients with evidence of decreasing hepatic synthetic functions, such as decreasing albumin levels or prolongation of prothrombin time, who nevertheless meet the entry criteria to start therapy, may be at increased risk of clinical decompensation if a flare of aminotransferases occurs during INTRON A treatment. In such patients, if increases in ALT occur during INTRON A therapy for chronic hepatitis B, they should be followed carefully, including close monitoring of clinical symptomatology and liver function tests including ALT, prothrombin time, alkaline phosphatase, albumin, and bilirubin. In considering these patients for INTRON A therapy, the potential risks must be evaluated against the potential benefits of treatment.
Peripheral Neuropathy
Peripheral neuropathy has been reported when alpha interferons were given in combination with telbivudine. In one clinical trial, an increased risk and severity of peripheral neuropathy was observed with the combination use of telbivudine and pegylated interferon alfa-2a as compared to telbivudine alone. The safety and efficacy of telbivudine in combination with interferons for the treatment of chronic hepatitis B has not been demonstrated.
Use with Ribavirin (see also REBETOL prescribing information)
REBETOL may cause birth defects and/or death of the unborn child. REBETOL therapy should not be started until a report of a negative pregnancy test has been obtained immediately prior to planned initiation of therapy. Patients should use at least two forms of contraception and have monthly pregnancy tests (see and ).
Combination treatment with INTRON A and REBETOL was associated with hemolytic anemia. Hemoglobin less than 10 g/dL was observed in approximately 10% of adult and pediatric patients in clinical trials. Anemia occurred within 1 to 2 weeks of initiation of ribavirin therapy. Combination treatment with INTRON A and REBETOL should be used in patients with creatinine clearance less than 50 mL/min. See REBETOL prescribing information for additional information.
What are the precautions of INTRON A?
General
Acute serious hypersensitivity reactions (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis) have been observed rarely in INTRON A-treated patients; if such an acute reaction develops, the drug should be discontinued immediately and appropriate medical therapy instituted. Transient rashes have occurred in some patients following injection, but have not necessitated treatment interruption.
While fever may be related to the flu-like syndrome reported commonly in patients treated with interferon, other causes of persistent fever should be ruled out.
There have been reports of interferon, including INTRON A, exacerbating preexisting psoriasis and sarcoidosis as well as development of new sarcoidosis. Therefore, INTRON A therapy should be used in these patients only if the potential benefit justifies the potential risk.
Variations in dosage, routes of administration, and adverse reactions exist among different brands of interferon. Therefore, do not use different brands of interferon in any single treatment regimen.
Triglycerides
Elevated triglyceride levels have been observed in patients treated with interferons, including INTRON A therapy. Elevated triglyceride levels should be managed as clinically appropriate. Hypertriglyceridemia may result in pancreatitis. Discontinuation of INTRON A therapy should be considered for patients with persistently elevated triglycerides (e.g., triglycerides greater than 1000 mg/dL) associated with symptoms of potential pancreatitis, such as abdominal pain, nausea, or vomiting.
Drug Interactions
Interactions between INTRON A and other drugs have not been fully evaluated. Caution should be exercised when administering INTRON A therapy in combination with other potentially myelosuppressive agents such as zidovudine. Concomitant use of alpha interferon and theophylline decreases theophylline clearance, resulting in a 100% increase in serum theophylline levels.
Information for Patients
Patients receiving INTRON A alone or in combination with REBETOL should be informed of the risks and benefits associated with treatment and should be instructed on proper use of the product. To supplement your discussion with a patient, you may wish to provide patients with a copy of the .
Patients should be informed of, and advised to seek medical attention for, symptoms indicative of serious adverse reactions associated with this product. Such adverse reactions may include depression (suicidal ideation), cardiovascular (chest pain), ophthalmologic toxicity (decrease in/or loss of vision), pancreatitis or colitis (severe abdominal pain), and cytopenias (high persistent fevers, bruising, dyspnea). Patients should be advised that some side effects such as fatigue and decreased concentration might interfere with the ability to perform certain tasks. Patients who are taking INTRON A in combination with REBETOL must be thoroughly informed of the risks to a fetus. Female patients and female partners of male patients must be told to use two forms of birth control during treatment and for six months after therapy is discontinued (see ).
Patients should be advised to remain well hydrated during the initial stages of treatment and that use of an antipyretic may ameliorate some of the flu-like symptoms.
If a decision is made to allow a patient to self-administer INTRON A, they should be instructed, based on their treatment, if they should inject a dose of INTRON A subcutaneously or intramuscularly. If it is too difficult for them to inject themselves, they should be instructed to ask someone who has been trained to give the injection to them. Patients should be instructed on the importance of site selection for self-administering the injection, as well as the importance on rotating the injection sites. A puncture resistant container for the disposal of needles and syringes should be supplied. Patients self-administering INTRON A should be instructed on the proper disposal of needles and syringes and cautioned against reuse.
Patients should be instructed that the Sterile Water for Injection vial supplied with Intron A Powder for Injection contains an excess amount of diluent (5 mL) and only 1 mL should be withdrawn to reconstitute Intron A Powder for Injection. The vial of Sterile Water for Injection is intended for single use only. Discard the unused portion of sterile water. Do not save or reuse.
Dental and Periodontal Disorders
Dental and periodontal disorders have been reported in patients receiving ribavirin and interferon combination therapy. In addition, dry mouth could have a damaging effect on teeth and mucous membranes of the mouth during long-term treatment with the combination of REBETOL and interferon alfa-2b. Patients should brush their teeth thoroughly twice daily and have regular dental examinations. In addition, some patients may experience vomiting. If this reaction occurs, they should be advised to rinse out their mouth thoroughly afterwards.
Laboratory Tests
- Standard hematologic tests — including hemoglobin, complete and differential white blood cell counts, and platelet count.
- Blood chemistries — electrolytes, liver function tests, and TSH.
- Monitor hepatic function with serum bilirubin, ALT (alanine transaminase), AST (aspartate aminotransferase), alkaline phosphatase, and LDH (lactate dehydrogenase) at 2, 8 and 12 weeks following initiation of INTRON A, then every 6 months while receiving INTRON A. Permanently discontinue INTRON A for evidence of severe (Grade 3) hepatic injury or hepatic decompensation (Child-Pugh score >6 [class B and C]).
In addition to those tests normally required for monitoring patients, the following laboratory tests are recommended for all patients on INTRON A therapy, prior to beginning treatment and then periodically thereafter.
Those patients who have preexisting cardiac abnormalities and/or are in advanced stages of cancer should have electrocardiograms taken prior to and during the course of treatment.
Mild-to-moderate leukopenia and elevated serum liver enzyme (SGOT) levels have been reported with intralesional administration of INTRON A (see ); therefore, the monitoring of these laboratory parameters should be considered.
Baseline chest X-rays are suggested and should be repeated if clinically indicated.
For malignant melanoma patients, differential WBC count and liver function tests should be monitored weekly during the induction phase of therapy and monthly during the maintenance phase of therapy.
For specific recommendations in chronic hepatitis C and chronic hepatitis B, see .
Carcinogenesis, Mutagenesis, Impairment of Fertility
Studies with INTRON A have not been performed to determine carcinogenicity.
Interferon may impair fertility. In studies of interferon administration in nonhuman primates, menstrual cycle abnormalities have been observed. Decreases in serum estradiol and progesterone concentrations have been reported in women treated with human leukocyte interferon. Therefore, fertile women should not receive INTRON A therapy unless they are using effective contraception during the therapy period. INTRON A therapy should be used with caution in fertile men.
Mutagenicity studies have demonstrated that INTRON A is not mutagenic.
Studies in mice (0.1, 1.0 million IU/day), rats (4, 20, 100 million IU/kg/day), and cynomolgus monkeys (1.1 million IU/kg/day; 0.25, 0.75, 2.5 million IU/kg/day) injected with INTRON A for up to 9 days, 3 months, and 1 month, respectively, have revealed no evidence of toxicity. However, in cynomolgus monkeys (4, 20, 100 million IU/kg/day) injected daily for 3 months with INTRON A, toxicity was observed at the mid and high doses and mortality was observed at the high dose.
However, due to the known species-specificity of interferon, the effects in animals are unlikely to be predictive of those in man.
INTRON A in combination with REBETOL should be used with caution in fertile men. See the REBETOL prescribing information for additional information.
Pregnancy Category C
INTRON A has been shown to have abortifacient effects in (rhesus monkeys) at 15 and 30 million IU/kg (estimated human equivalent of 5 and 10 million IU/kg, based on body surface area adjustment for a 60-kg adult). There are no adequate and well-controlled studies in pregnant women. INTRON A therapy should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Pregnancy Category X
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Ribavirin Pregnancy Registry
A Ribavirin Pregnancy Registry has been established to monitor maternal-fetal outcomes of pregnancies in female patients and female partners of male patients exposed to ribavirin during treatment and for 6 months following cessation of treatment. Physicians and patients are encouraged to report such cases by calling 1-800-593-2214.
Nursing Mothers
It is not known whether this drug is excreted in human milk. However, studies in mice have shown that mouse interferons are excreted into the milk. Because of the potential for serious adverse reactions from the drug in nursing infants, a decision should be made whether to discontinue nursing or to discontinue INTRON A therapy, taking into account the importance of the drug to the mother.
Pediatric Use
General
Safety and effectiveness in pediatric patients have not been established for indications other than chronic hepatitis B and chronic hepatitis C.
Chronic Hepatitis B
Safety and effectiveness in pediatric patients ranging in age from 1 to 17 years have been established based upon one controlled clinical trial (see and ).
Chronic Hepatitis C
Safety and effectiveness in pediatric patients ranging in age from 3 to 16 years have been established based upon clinical studies in 118 patients. See REBETOL prescribing information for additional information. Suicidal ideation or attempts occurred more frequently among pediatric patients compared to adult patients (2.4% versus 1%) during treatment and off-therapy follow-up (see ). During a 48-week course of therapy there was a decrease in the rate of linear growth (mean percentile assignment decrease of 7%) and a decrease in the rate of weight gain (mean percentile assignment decrease of 9%). A general reversal of these trends was noted during the 24-week post-treatment period.
Long-term data in a limited number of patients suggests that combination therapy may induce a growth inhibition that results in reduced final adult height in some patients (see ).
Geriatric Use
In all clinical studies of INTRON A, including studies as monotherapy and in combination with REBETOL (ribavirin USP) Capsules, only a small percentage of the subjects were aged 65 and over. These numbers were too few to determine if they respond differently from younger subjects except for the clinical trials of INTRON A in combination with REBETOL, where elderly subjects had a higher frequency of anemia (67%) than did younger patients (28%).
In a database consisting of clinical study and postmarketing reports for various indications, cardiovascular adverse events and confusion were reported more frequently in elderly patients receiving INTRON A therapy compared to younger patients.
In general, INTRON A therapy should be administered to elderly patients cautiously, reflecting the greater frequency of decreased hepatic, renal, bone marrow, and/or cardiac function and concomitant disease or other drug therapy. INTRON A is known to be substantially excreted by the kidney, and the risk of adverse reactions to INTRON A may be greater in patients with impaired renal function. Because elderly patients often have decreased renal function, patients should be carefully monitored during treatment, and dose adjustments made based on symptoms and/or laboratory abnormalities (see and ).
What are the side effects of INTRON A?
General
The adverse experiences listed below were reported to be possibly or probably related to INTRON A therapy during clinical trials. Most of these adverse reactions were mild to moderate in severity and were manageable. Some were transient and most diminished with continued therapy.
The most frequently reported adverse reactions were "flu-like" symptoms, particularly fever, headache, chills, myalgia, and fatigue. More severe toxicities are observed generally at higher doses and may be difficult for patients to tolerate.
| MALIGNANT MELANOMA | FOLLICULAR LYMPHOMA | HAIRY CELL LEUKEMIA | CONDYLOMATA ACUMINATA | AIDS-RELATED KAPOSI'S SARCOMA | CHRONIC HEPATITIS C | CHRONIC HEPATITIS B | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adults | Pediatrics | |||||||||
| N=143 | N=135 | N=145 | N=352 | N=74 | N=29 | N=183 | N=101 | N=78 | N=116 | |
| Application-Site Disorders | 20 | |||||||||
| injection site inflammation | -- | 1 | -- | -- | -- | -- | 5 | 3 | -- | -- |
| other (≤5%) | burning, injection site bleeding, injection site pain, injection site reaction (5% in chronic hepatitis B pediatrics), itching | |||||||||
| Blood Disorders (<5%) | anemia, anemia hypochromic, granulocytopenia, hemolytic anemia, leukopenia, lymphocytosis, neutropenia (9% in chronic hepatitis C, 14% in chronic hepatitis B pediatrics), thrombocytopenia (10% in chronic hepatitis C) (bleeding 8% in malignant melanoma), thrombocytopenia purpura | |||||||||
| Body as a Whole | ||||||||||
| facial edema | -- | 1 | -- | <1 | -- | 10 | <1 | 3 | 1 | <1 |
| weight decrease | 3 | 13 | <1 | <1 | 5 | 3 | 10 | 2 | 5 | 3 |
| other (≤5%) | allergic reaction, cachexia, dehydration, earache, hernia, edema, hypercalcemia, hyperglycemia, hypothermia, inflammation nonspecific, lymphadenitis, lymphadenopathy, mastitis, periorbital edema, poor peripheral circulation, peripheral edema (6% in follicular lymphoma), phlebitis superficial, scrotal/penile edema, thirst, weakness, weight increase | |||||||||
| Cardiovascular System Disorders (<5%) | angina, arrhythmia, atrial fibrillation, bradycardia, cardiac failure, cardiomegaly, cardiomyopathy, coronary artery disorder, extrasystoles, heart valve disorder, hematoma, hypertension (9% in chronic hepatitis C), hypotension, palpitations, phlebitis, postural hypotension, pulmonary embolism, Raynaud's disease, tachycardia, thrombosis, varicose vein | |||||||||
| Endocrine System Disorders (<5%) | aggravation of diabetes mellitus, goiter, gynecomastia, hyperglycemia, hyperthyroidism, hypertriglyceridemia, hypothyroidism, virilism | |||||||||
| Flu-like Symptoms | ||||||||||
| fever | 81 | 56 | 68 | 56 | 47 | 55 | 34 | 66 | 86 | 94 |
| headache | 62 | 21 | 39 | 47 | 36 | 21 | 43 | 61 | 44 | 57 |
| chills | 54 | -- | 46 | 45 | -- | -- | -- | -- | -- | -- |
| myalgia | 75 | 16 | 39 | 44 | 34 | 28 | 43 | 59 | 40 | 27 |
| fatigue | 96 | 8 | 61 | 18 | 84 | 48 | 23 | 75 | 69 | 71 |
| increased sweating | 6 | 13 | 8 | 2 | 4 | 21 | 4 | 1 | 1 | 3 |
| asthenia | -- | 63 | 7 | -- | 11 | -- | 40 | 5 | 15 | 5 |
| rigors | 2 | 7 | -- | -- | 30 | 14 | 16 | 38 | 42 | 30 |
| arthralgia | 6 | 8 | 8 | 9 | -- | 3 | 16 | 19 | 8 | 15 |
| dizziness | 23 | -- | 12 | 9 | 7 | 24 | 9 | 13 | 10 | 8 |
| influenza-like symptoms | 10 | 18 | 37 | -- | 45 | 79 | 26 | 5 | -- | <1 |
| back pain | -- | 15 | 19 | 6 | 1 | 3 | -- | -- | -- | -- |
| dry mouth | 1 | 2 | 19 | -- | 22 | 28 | 5 | 6 | 5 | -- |
| chest pain | 2 | 8 | <1 | <1 | 1 | 28 | 4 | 4 | -- | -- |
| malaise | 6 | -- | -- | 14 | 5 | -- | 13 | 9 | 6 | 3 |
| pain (unspecified) | 15 | 9 | 18 | 3 | 3 | 3 | -- | -- | -- | -- |
| other (<5%) | chest pain substernal, hyperthermia, rhinitis, rhinorrhea | |||||||||
| Gastrointestinal System Disorders | ||||||||||
| diarrhea | 35 | 19 | 18 | 2 | 18 | 45 | 13 | 19 | 8 | 12 |
| anorexia | 69 | 21 | 19 | 1 | 38 | 41 | 14 | 43 | 53 | 43 |
| nausea | 66 | 24 | 21 | 17 | 28 | 21 | 19 | 50 | 33 | 18 |
| taste alteration | 24 | 2 | 13 | <1 | 5 | 7 | 2 | 10 | -- | -- |
| abdominal pain | 2 | 20 | <5 | 1 | 5 | 21 | 16 | 5 | 4 | 23 |
| loose stools | -- | 1 | -- | <1 | -- | 10 | 2 | 2 | -- | 2 |
| vomiting | Vomiting was reported with nausea as a single term | 32 | 6 | 2 | 11 | 14 | 8 | 7 | 10 | 27 |
| constipation | 1 | 14 | <1 | -- | 1 | 10 | 4 | 5 | -- | 2 |
| gingivitis | 2 | 7 | -- | -- | -- | 14 | -- | 1 | -- | -- |
| dyspepsia | -- | 2 | -- | 2 | 4 | -- | 7 | 3 | 8 | 3 |
| other (<5%) | abdominal ascites, abdominal distension, colitis, dysphagia, eructation, esophagitis, flatulence, gallstones, gastric ulcer, gastritis, gastroenteritis, gastrointestinal disorder (7% in follicular lymphoma), gastrointestinal hemorrhage, gastrointestinal mucosal discoloration, gingival bleeding, gum hyperplasia, halitosis, hemorrhoids, increased appetite, increased saliva, intestinal disorder, melena, mouth ulceration, mucositis, oral hemorrhage, oral leukoplakia, rectal bleeding after stool, rectal hemorrhage, stomatitis, stomatitis ulcerative, taste loss, tongue disorder, tooth disorder | |||||||||
| Liver and Biliary System Disorders (<5%) | abnormal hepatic function tests, biliary pain, bilirubinemia, hepatitis, increased lactate dehydrogenase, increased transaminases (SGOT/SGPT) (elevated SGOT 63% in malignant melanoma and 24% in follicular lymphoma), jaundice, right upper quadrant pain (15% in chronic hepatitis C), and very rarely, hepatic encephalopathy, hepatic failure, and death | |||||||||
| Musculoskeletal System Disorders | ||||||||||
| musculoskeletal pain | -- | 18 | -- | -- | -- | -- | 21 | 9 | 1 | 10 |
| other (<5%) | arteritis, arthritis, arthritis aggravated, arthrosis, bone disorder, bone pain, carpal tunnel syndrome, hyporeflexia, leg cramps, muscle atrophy, muscle weakness, polyarteritis nodosa, tendinitis, rheumatoid arthritis, spondylitis | |||||||||
| Nervous System and Psychiatric Disorders | ||||||||||
| depression | 40 | 9 | 6 | 3 | 9 | 28 | 19 | 17 | 6 | 4 |
| paresthesia | 13 | 13 | 6 | 1 | 3 | 21 | 5 | 6 | 3 | <1 |
| impaired concentration | -- | 1 | -- | <1 | 3 | 14 | 3 | 8 | 5 | 3 |
| amnesia | Amnesia was reported with confusion as a single term | 1 | <5 | -- | -- | 14 | -- | -- | -- | -- |
| confusion | 8 | 2 | <5 | 4 | 12 | 10 | 1 | -- | -- | 2 |
| hypoesthesia | -- | 1 | <5 | 1 | -- | 10 | -- | -- | -- | -- |
| irritability | 1 | 1 | -- | -- | -- | -- | 13 | 16 | 12 | 22 |
| somnolence | 1 | 2 | <5 | 3 | 3 | -- | 33 | 14 | 9 | 5 |
| anxiety | 1 | 9 | 5 | <1 | 1 | 3 | 5 | 2 | -- | 3 |
| insomnia | 5 | 4 | -- | <1 | 3 | 3 | 12 | 11 | 6 | 8 |
| nervousness | 1 | 1 | -- | 1 | -- | 3 | 2 | 3 | -- | 3 |
| decreased libido | 1 | 1 | <5 | -- | -- | -- | 1 | 5 | 1 | -- |
| other (<5%) | abnormal coordination, abnormal dreaming, abnormal gait, abnormal thinking, aggravated depression, aggressive reaction, agitation (7% in chronic hepatitis B pediatrics), alcohol intolerance, apathy, aphasia, ataxia, Bell's palsy, CNS dysfunction, coma, convulsions, delirium, dysphonia, emotional lability, extrapyramidal disorder, feeling of ebriety, flushing, hearing disorder, hearing impairment, hot flashes, hyperesthesia, hyperkinesia, hypertonia, hypokinesia, impaired consciousness, labyrinthine disorder, loss of consciousness, manic depression, manic reaction, migraine, neuralgia, neuritis, neuropathy, neurosis, paresis, paroniria, parosmia, personality disorder, polyneuropathy, psychosis, speech disorder, stroke, suicidal ideation, suicide attempt, syncope, tinnitus, tremor, twitching, vertigo (8% in follicular lymphoma) | |||||||||
| Reproduction System Disorders (<5%) | amenorrhea (12% in follicular lymphoma), dysmenorrhea, impotence, leukorrhea, menorrhagia, menstrual irregularity, pelvic pain, penis disorder, sexual dysfunction, uterine bleeding, vaginal dryness | |||||||||
| Resistance Mechanism Disorders | ||||||||||
| moniliasis | -- | 1 | -- | <1 | -- | 17 | -- | -- | -- | -- |
| herpes simplex | 1 | 2 | -- | 1 | -- | 3 | 1 | 5 | -- | -- |
| other (<5%) | abscess, conjunctivitis, fungal infection, hemophilus, herpes zoster, infection, infection bacterial, infection nonspecific (7% in follicular lymphoma), infection parasitic, otitis media, sepsis, stye, trichomonas, upper respiratory tract infection, viral infection (7% in chronic hepatitis C) | |||||||||
| Respiratory System Disorders | ||||||||||
| dyspnea | 15 | 14 | <1 | -- | 1 | 34 | 3 | 5 | -- | -- |
| coughing | 6 | 13 | <1 | -- | -- | 31 | 1 | 4 | -- | 5 |
| pharyngitis | 2 | 8 | <5 | 1 | 1 | 31 | 3 | 7 | 1 | 7 |
| sinusitis | 1 | 4 | -- | -- | -- | 21 | 2 | -- | -- | -- |
| nonproductive coughing | 2 | 7 | -- | -- | -- | 14 | 0 | 1 | -- | -- |
| nasal congestion | 1 | 7 | -- | 1 | -- | 10 | <1 | 4 | -- | -- |
| other (≤5%) | asthma, bronchitis (10% in follicular lymphoma), bronchospasm, cyanosis, epistaxis (7% in chronic hepatitis B pediatrics), hemoptysis, hypoventilation, laryngitis, lung fibrosis, pleural effusion, orthopnea, pleural pain, pneumonia, pneumonitis, pneumothorax, rales, respiratory disorder, respiratory insufficiency, sneezing, tonsillitis, tracheitis, wheezing | |||||||||
| Skin and Appendages Disorders | ||||||||||
| dermatitis | 1 | -- | 8 | -- | -- | -- | 2 | 1 | -- | -- |
| alopecia | 29 | 23 | 8 | -- | 12 | 31 | 28 | 26 | 38 | 17 |
| pruritus | -- | 10 | 11 | 1 | 7 | -- | 9 | 6 | 4 | 3 |
| rash | 19 | 13 | 25 | -- | 9 | 10 | 5 | 8 | 1 | 5 |
| dry skin | 1 | 3 | 9 | -- | 9 | 10 | 4 | 3 | -- | <1 |
| other (<5%) | abnormal hair texture, acne, cellulitis, cyanosis of the hand, cold and clammy skin, dermatitis lichenoides, eczema, epidermal necrolysis, erythema, erythema nodosum, folliculitis, furunculosis, increased hair growth, lacrimal gland disorder, lacrimation, lipoma, maculopapular rash, melanosis, nail disorders, nonherpetic cold sores, pallor, peripheral ischemia, photosensitivity, pruritus genital, psoriasis, psoriasis aggravated, purpura (5% in chronic hepatitis C), rash erythematous, sebaceous cyst, skin depigmentation, skin discoloration, skin nodule, urticaria, vitiligo | |||||||||
| Urinary System Disorders (<5%) | albumin/protein in urine, cystitis, dysuria, hematuria, incontinence, increased BUN, micturition disorder, micturition frequency, nocturia, polyuria (10% in follicular lymphoma), renal insufficiency, urinary tract infection (5% in chronic hepatitis C) | |||||||||
| Vision Disorders (<5%) | abnormal vision, blurred vision, diplopia, dry eyes, eye pain, nystagmus, photophobia |
Hairy Cell Leukemia
The adverse reactions most frequently reported during clinical trials in 145 patients with hairy cell leukemia were the "flu-like" symptoms of fever (68%), fatigue (61%), and chills (46%).
Malignant Melanoma
The INTRON A dose was modified because of adverse events in 65% (n=93) of the patients. INTRON A therapy was discontinued because of adverse events in 8% of the patients during induction and 18% of the patients during maintenance. The most frequently reported adverse reaction was fatigue, which was observed in 96% of patients. Other adverse reactions that were recorded in greater than 20% of INTRON A-treated patients included neutropenia (92%), fever (81%), myalgia (75%), anorexia (69%), vomiting/nausea (66%), increased SGOT (63%), headache (62%), chills (54%), depression (40%), diarrhea (35%), alopecia (29%), altered taste sensation (24%), dizziness/vertigo (23%), and anemia (22%).
Adverse reactions classified as severe or life threatening (ECOG Toxicity Criteria grade 3 or 4) were recorded in 66% and 14% of INTRON A-treated patients, respectively. Severe adverse reactions recorded in greater than 10% of INTRON A-treated patients included neutropenia/leukopenia (26%), fatigue (23%), fever (18%), myalgia (17%), headache (17%), chills (16%), and increased SGOT (14%). Grade 4 fatigue was recorded in 4% and grade 4 depression was recorded in 2% of INTRON A-treated patients. No other grade 4 AE was reported in more than 2 INTRON A-treated patients. Lethal hepatotoxicity occurred in 2 INTRON A-treated patients early in the clinical trial. No subsequent lethal hepatotoxicities were observed with adequate monitoring of liver function tests (see ).
Follicular Lymphoma
Ninety-six percent of patients treated with CHVP plus INTRON A therapy and 91% of patients treated with CHVP alone reported an adverse event of any severity. Asthenia, fever, neutropenia, increased hepatic enzymes, alopecia, headache, anorexia, "flu-like" symptoms, myalgia, dyspnea, thrombocytopenia, paresthesia, and polyuria occurred more frequently in the CHVP plus INTRON A-treated patients than in patients treated with CHVP alone. Adverse reactions classified as severe or life threatening (World Health Organization grade 3 or 4) recorded in greater than 5% of CHVP plus INTRON A-treated patients included neutropenia (34%), asthenia (10%), and vomiting (10%). The incidence of neutropenic infection was 6% in CHVP plus INTRON A versus 2% in CHVP alone. One patient in each treatment group required hospitalization.
Twenty-eight percent of CHVP plus INTRON A-treated patients had a temporary modification/interruption of their INTRON A therapy, but only 13 patients (10%) permanently stopped INTRON A therapy because of toxicity. There were four deaths on study; two patients committed suicide in the CHVP plus INTRON A arm and two patients in the CHVP arm had unwitnessed sudden death. Three patients with hepatitis B (one of whom also had alcoholic cirrhosis) developed hepatotoxicity leading to discontinuation of INTRON A. Other reasons for discontinuation included intolerable asthenia (5/135), severe flu symptoms (2/135), and one patient each with exacerbation of ankylosing spondylitis, psychosis, and decreased ejection fraction.
Condylomata Acuminata
Eighty-eight percent (311/352) of patients treated with INTRON A for condylomata acuminata who were evaluable for safety reported an adverse reaction during treatment. The incidence of the adverse reactions reported increased when the number of treated lesions increased from one to five. All 40 patients who had five warts treated reported some type of adverse reaction during treatment.
Adverse reactions and abnormal laboratory test values reported by patients who were re-treated were qualitatively and quantitatively similar to those reported during the initial INTRON A treatment period.
AIDS-Related Kaposi's Sarcoma
In patients with AIDS-Related Kaposi's Sarcoma, some type of adverse reaction occurred in 100% of the 74 patients treated with 30 million IU/m three times a week and in 97% of the 29 patients treated with 35 million IU per day.
Of these adverse reactions, those classified as severe (World Health Organization grade 3 or 4) were reported in 27% to 55% of patients. Severe adverse reactions in the 30 million IU/m TIW study included: fatigue (20%), influenza-like symptoms (15%), anorexia (12%), dry mouth (4%), headache (4%), confusion (3%), fever (3%), myalgia (3%), and nausea and vomiting (1% each). Severe adverse reactions for patients who received the 35 million IU QD included: fever (24%), fatigue (17%), influenza-like symptoms (14%), dyspnea (14%), headache (10%), pharyngitis (7%), and ataxia, confusion, dysphagia, GI hemorrhage, abnormal hepatic function, increased SGOT, myalgia, cardiomyopathy, face edema, depression, emotional lability, suicide attempt, chest pain, and coughing (1 patient each). Overall, the incidence of severe toxicity was higher among patients who received the 35 million IU per day dose.
Chronic Hepatitis C
Two studies of extended treatment (18-24 months) with INTRON A show that approximately 95% of all patients treated experience some type of adverse event and that patients treated for extended duration continue to experience adverse events throughout treatment. Most adverse events reported are mild to moderate in severity. However, 29/152 (19%) of patients treated for 18 to 24 months experienced a serious adverse event compared to 11/163 (7%) of those treated for 6 months. Adverse events which occur or persist during extended treatment are similar in type and severity to those occurring during short-course therapy.
Of the patients achieving a complete response after 6 months of therapy, 12/79 (15%) subsequently discontinued INTRON A treatment during extended therapy because of adverse events, and 23/79 (29%) experienced severe adverse events (WHO grade 3 or 4) during extended therapy.
In patients using combination treatment with INTRON A and REBETOL, the primary toxicity observed was hemolytic anemia. Reductions in hemoglobin levels occurred within the first 1 to 2 weeks of therapy. Cardiac and pulmonary events associated with anemia occurred in approximately 10% of patients treated with INTRON A/REBETOL therapy. See REBETOL prescribing information for additional information.
Chronic Hepatitis C
In pediatric patients with chronic hepatitis C treated with INTRON A 3 MIU/m three times weekly and REBETOL 15 mg/kg per day, all subjects (n=118) had at least one adverse event during 24-48 weeks of treatment, of which 80% were considered to be mild or moderate in severity. Six percent discontinued therapy due to adverse reactions and dose modifications were required in 30% of subjects, most commonly for anemia and neutropenia. Adverse events occurring in more than 50% of subjects included headache, fever, fatigue and anorexia. Adverse events occurring in 20-50% of subjects included influenza-like symptoms, abdominal pain, vomiting, nausea, myalgia, pharyngitis, diarrhea, viral infection, rigors, weight decrease, musculoskeletal pain, alopecia and dizziness. The most common laboratory test abnormalities were neutropenia (34%) and anemia (27%). Depression was reported in 13% (n=15) of children. Three of these subjects had suicidal ideation, and one attempted suicide. Weight loss and slowed growth are common in pediatric patients during combination therapy with INTRON A and REBETOL. Following treatment, rebound growth and weight gain occurred in most subjects. Long-term follow-up data in pediatric subjects, however, indicates that INTRON A in combination with REBETOL may induce a growth inhibition that results in reduced adult height in some patients (see .
Chronic Hepatitis B
In patients with chronic hepatitis B, some type of adverse reaction occurred in 98% of the 101 patients treated at 5 million IU QD and 90% of the 78 patients treated at 10 million IU TIW. Most of these adverse reactions were mild to moderate in severity, were manageable, and were reversible following the end of therapy.
Adverse reactions classified as severe (causing a significant interference with normal daily activities or clinical state) were reported in 21% to 44% of patients. The severe adverse reactions reported most frequently were the "flu-like" symptoms of fever (28%), fatigue (15%), headache (5%), myalgia (4%), rigors (4%), and other severe "flu-like" symptoms, which occurred in 1% to 3% of patients. Other severe adverse reactions occurring in more than one patient were alopecia (8%), anorexia (6%), depression (3%), nausea (3%), and vomiting (2%).
To manage side effects, the dose was reduced, or INTRON A therapy was interrupted in 25% to 38% of patients. Five percent of patients discontinued treatment due to adverse experiences.
Chronic Hepatitis B
In pediatric patients with chronic hepatitis B (n=72) during 16-24 weeks of treatment, the most frequently reported adverse events were those commonly associated with interferon treatment: flu-like symptoms (100%), gastrointestinal system disorders (46%), and nausea and vomiting (40%). Neutropenia (13%) and thrombocytopenia (3%) were also reported. None of the adverse events was life threatening and most were moderate to severe and resolved upon dose reduction or drug discontinuation.
| MALIGNANT MELANOMA | FOLLICULAR LYMPHOMA | HAIRY CELL LEUKEMIA | CONDYLOMATA ACUMINATA | AIDS-RELATED KAPOSI'S SARCOMA | CHRONIC HEPATITIS C | CHRONIC HEPATITIS B | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Adults | Pediatrics | ||||||||||
| Laboratory Tests | N=143 | N=135 | N=145 | N=352 | N=69-73 | N=26-28 | N=140-171 | N=96-101 | N=75-103 | N=113-115 | |
| Hemoglobin | 22 | 8 | NA | -- | 1 | 15 | 26 | 32 | 23 | 17 | |
| White Blood Cell Count | White Blood Cell Count was reported as neutropenia | -- | NA | 17 | 10 | 22 | 26 | 68 | 34 | 9 | |
| Platelet Count | 15 | 13 | NA | -- | 0 | 8 | 15 | 12 | 5 | 1 | |
| Serum Creatinine | 3 | 2 | 0 | -- | -- | -- | 6 | 3 | 0 | 3 | |
| Alkaline Phosphatase | 13 | -- | 4 | -- | -- | -- | -- | 8 | 4 | 0 | |
| Lactate Dehydrogenase | 1 | -- | 0 | -- | -- | -- | -- | -- | -- | -- | |
| Serum Urea Nitrogen | 12 | 4 | 0 | -- | -- | -- | -- | 2 | 0 | 2 | |
| SGOT | 63 | 24 | 4 | 12 | 11 | 41 | -- | -- | -- | -- | |
| SGPT | 2 | -- | 13 | -- | 10 | 15 | -- | -- | -- | -- | |
| Granulocyte Count | |||||||||||
| Array | Total | 92 | 36 | NA | -- | 31 | 39 | 45 | 75 | 61 | 70 |
| Array | 1000-<1500/mm | 66 | -- | -- | -- | -- | -- | 32 | 30 | 32 | 43 |
| Array | 750-<1000/mm | -- | 21 | -- | -- | -- | -- | 10 | 24 | 18 | 18 |
| Array | 500-<750/mm | 25 | -- | -- | -- | -- | -- | 1 | 17 | 9 | 7 |
| Array | <500/mm | 1 | 13 | -- | -- | -- | -- | 2 | 4 | 2 | 2 |
Postmarketing Experience
The following adverse reactions have been identified during postapproval use of INTRON A alone or in combination with REBETOL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Blood and Lymphatic System Disorders
pancytopenia (concurrent anemia, leukopenia, thrombocytopenia), aplastic anemia, pure red cell aplasia, thrombotic thrombocytopenic purpura, idiopathic thrombocytopenic purpura
Cardiac Disorders
pericarditis
Ear and Labyrinth Disorders
hearing loss
Endocrine Disorders
hypopituitarism
Eye Disorders
Vogt-Koyanagi-Harada syndrome, serous retinal detachment
Gastrointestinal Disorders
pancreatitis
General Disorders and Administration Site Conditions
asthenic conditions (including asthenia, malaise, fatigue)
Immune System Disorders
cases of acute hypersensitivity reactions, including anaphylaxis and angioedema, systemic lupus erythematosus, sarcoidosis or exacerbation of sarcoidosis
Infections and Infestations
hepatitis B virus reactivation in HCV/HBV co-infected patients
Musculoskeletal and Connective Tissue Disorders
myositis
Nervous System Disorders
peripheral neuropathy
Psychiatric Disorders
homicidal ideation, psychosis including hallucinations
Renal and Urinary Disorders
renal failure, renal insufficiency, nephrotic syndrome
Respiratory, Thoracic, and Mediastinal Disorders
pulmonary hypertension, pulmonary fibrosis
Skin and Subcutaneous Tissue Disorders
injection site necrosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, urticaria
What should I look out for while using INTRON A?
INTRON A is contraindicated in patients with:
INTRON A and REBETOL combination therapy is additionally contraindicated in:
See REBETOL prescribing information for additional information.
What might happen if I take too much INTRON A?
There is limited experience with overdosage. Postmarketing surveillance includes reports of patients receiving a single dose as great as 10 times the recommended dose. In general, the primary effects of an overdose are consistent with the effects seen with therapeutic doses of interferon alfa-2b. Hepatic enzyme abnormalities, renal failure, hemorrhage, and myocardial infarction have been reported with single administration overdoses and/or with longer durations of treatment than prescribed (see ). Toxic effects after ingestion of interferon alfa-2b are not expected because interferons are poorly absorbed orally. Consultation with a poison center is recommended.
How should I store and handle INTRON A?
Potassium citrate extended-release tablets 5 mEq are uncoated, tan to yellowish in color, modified ball shaped, debossed with "USL" on one side and "070" on the other, supplied in bottles as:Potassium citrate extended-release tablets 10 mEq are uncoated, tan to yellowish in color, elliptical shaped, debossed with "USL" on one side and "071" on the other, supplied in bottles as:Potassium citrate extended-release tablets 5 mEq are uncoated, tan to yellowish in color, modified ball shaped, debossed with "USL" on one side and "070" on the other, supplied in bottles as:Potassium citrate extended-release tablets 10 mEq are uncoated, tan to yellowish in color, elliptical shaped, debossed with "USL" on one side and "071" on the other, supplied in bottles as:
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The interferons are a family of naturally occurring small proteins and glycoproteins with molecular weights of approximately 15,000 to 27,600 daltons produced and secreted by cells in response to viral infections and to synthetic or biological inducers.
Non-Clinical Toxicology
INTRON A is contraindicated in patients with:INTRON A and REBETOL combination therapy is additionally contraindicated in:
See REBETOL prescribing information for additional information.
Interactions between INTRON A and other drugs have not been fully evaluated. Caution should be exercised when administering INTRON A therapy in combination with other potentially myelosuppressive agents such as zidovudine. Concomitant use of alpha interferon and theophylline decreases theophylline clearance, resulting in a 100% increase in serum theophylline levels.
Acute serious hypersensitivity reactions (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis) have been observed rarely in INTRON A-treated patients; if such an acute reaction develops, the drug should be discontinued immediately and appropriate medical therapy instituted. Transient rashes have occurred in some patients following injection, but have not necessitated treatment interruption.
While fever may be related to the flu-like syndrome reported commonly in patients treated with interferon, other causes of persistent fever should be ruled out.
There have been reports of interferon, including INTRON A, exacerbating preexisting psoriasis and sarcoidosis as well as development of new sarcoidosis. Therefore, INTRON A therapy should be used in these patients only if the potential benefit justifies the potential risk.
Variations in dosage, routes of administration, and adverse reactions exist among different brands of interferon. Therefore, do not use different brands of interferon in any single treatment regimen.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).