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Vidaza
Overview
What is Vidaza?
Vidaza™ (azacitidine for injectable suspension) contains azacitidine, which is a pyrimidine nucleoside analog of cytidine. Azacitidine is 4-amino-1-β-D-ribofuranosyl-s-triazin-2(1)-one. The structural formula is as follows:
The empirical formula is CHNO The molecular weight is 244. Azacitidine is a white to off-white solid. Azacitidine was found to be insoluble in acetone, ethanol, and methyl ethyl ketone; slightly soluble in ethanol/water (50/50), propylene glycol, and polyethylene glycol; sparingly soluble in water, water saturated octanol, 5% dextrose in water, N-methyl-2-pyrrolidone, normal saline and 5% Tween 80 in water; and soluble in dimethylsulfoxide (DMSO).
The finished product is supplied in a sterile form for reconstitution and subcutaneous injection only. Vials of Vidaza contain 100 mg of azacitidine and 100 mg mannitol as a sterile lyophilized powder.
What does Vidaza look like?
What are the available doses of Vidaza?
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What should I talk to my health care provider before I take Vidaza?
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How should I use Vidaza?
Vidaza is indicated for treatment of patients with the following myelodysplastic syndrome subtypes: refractory anemia or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia.
The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m subcutaneously, daily for seven days. Patients should be premedicated for nausea and vomiting.
What interacts with Vidaza?
Vidaza is contraindicated in patients with a known hypersensitivity to azacitidine or mannitol. Vidaza is also contraindicated in patients with advanced malignant hepatic tumors. (See ).
What are the warnings of Vidaza?
Pregnancy - Teratogenic Effects: Pregnancy Category D
Vidaza may cause fetal harm when administered to a pregnant woman. Early embryotoxicity studies in mice revealed a 44% frequency of intrauterine embryonal death (increased resorption) after a single IP (intraperitoneal) injection of 6 mg/m (approximately 8% of the recommended human daily dose on a mg/m basis) azacitidine on gestation day 10. Developmental abnormalities in the brain have been detected in mice given azacitidine on or before gestation day 15 at doses of ~3-12 mg/m (approximately 4%-16% the recommended human daily dose on a mg/m basis).
In rats, azacitidine was clearly embryotoxic when given IP on gestation days 4-8 (postimplantation) at a dose of 6 mg/m (approximately 8% of the recommended human daily dose on a mg/m basis), although treatment in the preimplantation period (on gestation days 1-3) had no adverse effect on the embryos. Azacitidine caused multiple fetal abnormalities in rats after a single IP dose of 3 to 12 mg/m (approximately 8% the recommended human daily dose on a mg/m basis) given on gestation day 9, 10, 11 or 12. In this study azacitidine caused fetal death when administered at 3-12 mg/m on gestation days 9 and 10; average live animals per litter was reduced to 9% of control at the highest dose on gestation day 9. Fetal anomalies included: CNS anomalies (exencephaly/encephalocele), limb anomalies (micromelia, club foot, syndactyly, oligodactyly), and others (micrognathia, gastroschisis, edema, and rib abnormalities).
There are no adequate and well-controlled studies in pregnant women using Vidaza. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with Vidaza.
Use in Males
Men should be advised to not father a child while receiving treatment with Vidaza. (See for discussion of pre-mating effects of azacitidine exposure on male fertility and embryonic viability.)
What are the precautions of Vidaza?
General
Treatment with Vidaza is associated with neutropenia and thrombocytopenia. Complete blood counts should be performed as needed to monitor response and toxicity, but at a minimum, prior to each dosing cycle. After administration of the recommended dosage for the first cycle, dosage for subsequent cycles should be reduced or delayed based on nadir counts and hematologic response as described in .
Safety and effectiveness of Vidaza in patients with MDS and hepatic or renal impairment have not been studied as these patients were excluded from the clinical trials.
Because azacitidine is potentially hepatotoxic in patients with severe pre-existing hepatic impairment, caution is needed in patients with liver disease. Patients with extensive tumor burden due to metastatic disease have been rarely reported to experience progressive hepatic coma and death during azacitidine treatment, especially in such patients with baseline albumin <30 g/L. Azacitidine is contraindicated in patients with advanced malignant hepatic tumors (See ).
Renal abnormalities ranging from elevated serum creatinine to renal failure and death have been reported rarely in patients treated with intravenous azacitidine in combination with other chemotherapeutic agents for non-MDS conditions. In addition, renal tubular acidosis, defined as a fall in serum bicarbonate to <20 mEq/L in association with an alkaline urine and hypokalemia (serum potassium <3 mEq/L) developed in 5 patients with CML treated with azacitidine and etoposide. If unexplained reductions in serum bicarbonate <20 mEq/L or elevations of BUN or serum creatinine occur, the dosage should be reduced or held as described in
Patients with renal impairment should be closely monitored for toxicity since azacitidine and its metabolites are primarily excreted by the kidneys (see section).
Information for Patients
Patients should inform their physician about any underlying liver or renal disease.
Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with Vidaza.
Men should be advised to not father a child while receiving treatment with Vidaza.
Laboratory Tests
Complete blood counts should be performed as needed to monitor response and toxicity, but at a minimum, prior to each cycle. Liver chemistries and serum creatinine should be obtained prior to initiation of therapy.
Drug Interactions
No formal assessments of drug-drug interactions between Vidaza and other agents have been conducted. (See )
Carcinogenesis, Mutagenesis, Impairment of Fertility
The potential carcinogenicity of azacitidine was evaluated in mice and rats. Azacitidine induced tumors of the hematopoietic system in female mice at 2.2 mg/kg (6.6 mg/m, approximately 8% the recommended human daily dose on a mg/m basis) administered IP three times per week for 52 weeks. An increased incidence of tumors in the lymphoreticular system, lung, mammary gland, and skin was seen in mice treated with azacitidine IP at 2.0 mg/kg (6.0 mg/m, approximately 8% the recommended human daily dose on a mg/m basis) once a week for 50 weeks. A tumorigenicity study in rats dosed twice weekly at 15 or 60 mg/m (approximately 20-80% the recommended human daily dose on a mg/m basis) revealed an increased incidence of testicular tumors compared with controls.
The mutagenic and clastogenic potential of azacitidine was tested in bacterial systemsstrains TA100 and several strains of strains WP14 Pro, WP3103P, WP3104P, and CC103; inforward gene mutation assay in mouse lymphoma cells and human lymphoblast cells; and in anmicronucleus assay in mouse L5178Y lymphoma cells and Syrian hamster embryo cells. Azacitidine was mutagenic in bacterial and mammalian cell systems. The clastogenic effect of azacitidine was shown by the induction of micronuclei in L5178Y mouse cells and Syrian hamster embryo cells.
Administration of azacitidine to male mice at 9.9 mg/m (approximately 9% the recommended human daily dose on a mg/m basis) daily for 3 days prior to mating with untreated female mice resulted in decreased fertility and loss of offspring during subsequent embryonic and postnatal development. Treatment of male rats three times per week for 11 or 16 weeks at doses of 15 to 30 mg/m (approximately 20-40%, the recommended human daily dose on a mg/m basis) resulted in decreased weight of the testes and epididymides, and decreased sperm counts accompanied by decreased pregnancy rates and increased loss of embryos in mated females. In a related study, male rats treated for 16 weeks at 24 mg/m resulted in an increase in abnormal embryos in mated females when examined on day 2 of gestation. See .
Pregnancy
Nursing Mothers
It is not known whether azacitidine or its metabolites are excreted in human milk. Because of the potential for tumorigenicity shown for azacitidine in animal studies and the potential for serious adverse reactions, women treated with azacitidine should not nurse.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
Of the total number of patients in the three clinical studies described in , above, 62 percent were 65 years and older and 21 percent were 75 years and older. No overall differences in effectiveness were observed between these patients and younger patients. In addition there were no relevant differences in the frequency of adverse events observed in patients 65 years and older compared to younger patients.
Azacitidine and its metabolites are known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, it may be useful to monitor renal function (see section).
What are the side effects of Vidaza?
Overview
Adverse Reactions Described in Other Labeling Sections:
Most Commonly Occurring Adverse Reactions (SC Route):
Adverse Reactions Most Frequently (>2%) Resulting in Clinical Intervention (SC Route):
Discontinuation
Dose Held
Dose Reduced
Discussion of Adverse Reactions Information
The data described below reflect exposure to Vidaza in 268 patients, including 116 exposed for 6 cycles (approximately 6 months) or more and 60 exposed for greater than 12 cycles (approximately one year). Vidaza was studied primarily in supportive care-controlled and uncontrolled trials (n= 150 and n=118, respectively). The population in the subcutaneous studies (n = 220) was 23 to 92 years old (mean 66.4 years), 68% male, and 94% white, and had MDS or AML. The population in the IV study (n = 48) was 35 to 81 years old (mean 63.1 years), 65% male, and 100% white. Most patients received average daily doses between 50 and 100 mg/m.
The following table presents the most common adverse events, whether or not considered drug related by investigators, occurring in at least 5% of patients treated with Vidaza in the supportive care-controlled trial and the uncontrolled subcutaneous trial combined. It is important to note that duration of exposure was longer for the Vidaza-treated group than for the observation group: patients received Vidaza for a mean of 11.4 months while mean time in the observation arm was 6.1 months.
Nausea, vomiting, diarrhea, and constipation all tended to increase in incidence with increasing doses of Vidaza. Nausea, vomiting, injection site erythema, constipation, rigors, petechiae, injection site pain, dizziness, injection site bruising, anxiety, hypokalemia, insomnia, epistaxis, and rales tended to be more pronounced during the first 1-2 cycles of SC Vidaza treatment compared with later cycles of treatment. There did not appear to be any adverse events that increased in frequency over the course of treatment. There did not appear to be any relevant differences in adverse events by gender.
In clinical studies of either SC or IV Vidaza, the following serious treatment-related adverse events occurring at a rate of <5% (not described in ) were reported:
Blood and lymphatic system disorders:
Cardiac disorders:
Gastrointestinal disorders:
General disorders and administration site conditions:
Hepatobiliary disorders:
Immune system disorders:
Infections and infestations:
Metabolism and nutrition disorders:
Musculoskeletal and connective tissue disorders:
Neoplasms benign, malignant and unspecified:
Nervous system disorders:
Psychiatric disorders:
Renal and urinary disorders:
Respiratory, thoracic and mediastinal disorders:
Skin and subcutaneous tissue disorders:
Surgical and medical procedures:
Vascular disorders:
| * | |||
| ** | |||
| † Includes events from observation period only; excludes any events after crossover to Vidaza. | |||
| ‡ Includes events from all patients exposed to Vidaza, including patients after crossing over from observation. | |||
| Preferred Term** | All Vidaza‡(N=220) | Observation†(N=92) | |
|---|---|---|---|
| 219 (99.5) | 89 (96.7) | ||
| Nausea | 155 (70.5) | 16 (17.4) | |
| Anemia | 153 (69.5) | 59 (64.1) | |
| Thrombocytopenia | 144 (65.5) | 42 (45.7) | |
| Vomiting | 119 (54.1) | 5 (5.4) | |
| Pyrexia | 114 (51.8) | 28 (30.4) | |
| Leukopenia | 106 (48.2) | 27 (29.3) | |
| Diarrhea | 80 (36.4) | 13 (14.1) | |
| Fatigue | 79 (35.9) | 23 (25.0) | |
| Injection site erythema | 77 (35.0) | 0 | |
| Constipation | 74 (33.6) | 6 (6.5) | |
| Neutropenia | 71 (32.3) | 10 (10.9) | |
| Ecchymosis | 67 (30.5) | 14 (15.2) | |
| Cough | 65 (29.5) | 14 (15.2) | |
| Dyspnea | 64 (29.1) | 11 (12.0) | |
| Weakness | 64 (29.1) | 19 (20.7) | |
| Rigors | 56 (25.5) | 10 (10.9) | |
| Petechiae | 52 (23.6) | 8 (8.7) | |
| Injection site pain | 50 (22.7) | 0 | |
| Arthralgia | 49 (22.3) | 3 (3.3) | |
| Headache | 48 (21.8) | 10 (10.9) | |
| Anorexia | 45 (20.5) | 6 (6.5) | |
| Pain in limb | 44 (20.0) | 5 (5.4) | |
| Pharyngitis | 44 (20.0) | 7 (7.6) | |
| Back pain | 41 (18.6) | 7 (7.6) | |
| Contusion | 41 (18.6) | 9 (9.8) | |
| Dizziness | 41 (18.6) | 5 (5.4) | |
| Edema peripheral | 41 (18.6) | 10 (10.9) | |
| Erythema | 37 (16.8) | 4 (4.3) | |
| Chest pain | 36 (16.4) | 5 (5.4) | |
| Epistaxis | 36 (16.4) | 9 (9.8) | |
| Febrile neutropenia | 36 (16.4) | 4 (4.3) | |
| Myalgia | 35 (15.9) | 2 (2.2) | |
| Weight decreased | 35 (15.9) | 10 (10.9) | |
| Abdominal pain | 34 (15.5) | 12 (13.0) | |
| Pallor | 34 (15.5) | 7 (7.6) | |
| Nasopharyngitis | 32 (14.5) | 3 (3.3) | |
| Pitting edema | 32 (14.5) | 9 (9.8) | |
| Skin lesion | 32 (14.5) | 8 (8.7) | |
| Dyspnea exertional | 31 (14.1) | 15 (16.3) | |
| Injection site bruising | 31 (14.1) | 0 | |
| Rash | 31 (14.1) | 9 (9.8) | |
| Injection site reaction | 30 (13.6) | 0 | |
| Anxiety | 29 (13.2) | 3 (3.3) | |
| Appetite decreased | 28 (12.7) | 8 (8.7) | |
| Fatigue aggravated | 28 (12.7) | 4 (4.3) | |
| Hypokalemia | 28 (12.7) | 12 (13.0) | |
| Upper respiratory tract infection | 28 (12.7) | 4 (4.3) | |
| Pruritus | 27 (12.3) | 11 (12.0) | |
| Abdominal tenderness | 26 (11.8) | 1 (1.1) | |
| Depression | 26 (11.8) | 7 (7.6) | |
| Productive cough | 25 (11.4) | 4 (4.3) | |
| Insomnia | 24 (10.9) | 4 (4.3) | |
| Malaise | 24 (10.9) | 1 (1.1) | |
| Pain | 24 (10.9) | 3 (3.3) | |
| Pneumonia | 24 (10.9) | 5 (5.4) | |
| Abdominal pain upper | 23 (10.5) | 3 (3.3) | |
| Crackles lung | 23 (10.5) | 8 (8.7) | |
| Sweating increased | 23 (10.5) | 2 (2.2) | |
| Cardiac murmur | 22 (10.0) | 8 (8.7) | |
| Rhinorrhea | 22 (10.0) | 2 (2.2) | |
| Gingival bleeding | 21 (9.5) | 4 (4.3) | |
| Lymphadenopathy | 21 (9.5) | 3 (3.3) | |
| Herpes simplex | 20 (9.1) | 5 (5.4) | |
| Hematoma | 19 (8.6) | 0 | |
| Night sweats | 19 (8.6) | 3 (3.3) | |
| Rales | 19 (8.6) | 8 (8.7) | |
| Tachycardia | 19 (8.6) | 6 (6.5) | |
| Wheezing | 19 (8.6) | 2 (2.2) | |
| Cellulitis | 18 (8.2) | 4 (4.3) | |
| Dysuria | 18 (8.2) | 2 (2.2) | |
| Breath sounds decreased | 17 (7.7) | 1 (1.1) | |
| Lethargy | 17 (7.7) | 2 (2.2) | |
| Oral mucosal petechiae | 17 (7.7) | 3 (3.3) | |
| Stomatitis | 17 (7.7) | 0 | |
| Urinary tract infection | 17 (7.7) | 5 (5.4) | |
| Peripheral swelling | 16 (7.3) | 5 (5.4) | |
| Dyspepsia | 15 (6.8) | 4 (4.3) | |
| Hemorrhoids | 15 (6.8) | 1 (1.1) | |
| Hypotension | 15 (6.8) | 2 (2.2) | |
| Injection site pruritus | 15 (6.8) | 0 | |
| Transfusion reaction | 15 (6.8) | 0 | |
| Pleural effusion | 14 (6.4) | 6 (6.5) | |
| Abdominal distension | 13 (5.9) | 4 (4.3) | |
| Muscle cramps | 13 (5.9) | 3 (3.3) | |
| Post procedural hemorrhage | 13 (5.9) | 1 (1.1) | |
| Postnasal drip | 13 (5.9) | 3 (3.3) | |
| Rhonchi | 13 (5.9) | 2 (2.2) | |
| Syncope | 13 (5.9) | 5 (5.4) | |
| Urticaria | 13 (5.9) | 1 (1.1) | |
| Anemia aggravated | 12 (5.5) | 5 (5.4) | |
| Loose stools | 12 (5.5) | 0 | |
| Nasal congestion | 12 (5.5) | 1 (1.1) | |
| Atelectasis | 11 (5.0) | 2 (2.2) | |
| Chest wall pain | 11 (5.0) | 0 | |
| Dry skin | 11 (5.0) | 1 (1.1) | |
| Dysphagia | 11 (5.0) | 2 (2.2) | |
| Dyspnea exacerbated | 11 (5.0) | 3 (3.3) | |
| Hypoesthesia | 11 (5.0) | 1 (1.1) | |
| Injection site granuloma | 11 (5.0) | 0 | |
| Injection site pigmentation changes | 11 (5.0) | 0 | |
| Injection site swelling | 11 (5.0) | 0 | |
| Mouth hemorrhage | 11 (5.0) | 1 (1.1) | |
| Post procedural pain | 11 (5.0) | 2 (2.2) | |
| Sinusitis | 11 (5.0) | 3 (3.3) | |
| Skin nodule | 11 (5.0) | 1 (1.1) | |
| Tongue ulceration | 11 (5.0) | 2 (2.2) |
What should I look out for while using Vidaza?
Vidaza is contraindicated in patients with a known hypersensitivity to azacitidine or mannitol. Vidaza is also contraindicated in patients with advanced malignant hepatic tumors. (See ).
What might happen if I take too much Vidaza?
One case of overdose with Vidaza was reported during clinical trials. A patient experienced diarrhea, nausea, and vomiting after receiving a single IV dose of approximately 290 mg/m, almost 4 times the recommended starting dose. The events resolved without sequelae, and the correct dose was resumed the following day. In the event of overdosage, the patient should be monitored with appropriate blood counts and should receive supportive treatment, as necessary. There is no known specific antidote for Vidaza overdosage.
How should I store and handle Vidaza?
Store unreconstituted vials at 25° C (77° F); excursions permitted to 15°-30° C (59°-86° F) (See USP Controlled Room Temperature).Vidaza (azacitidine for injectable suspension) is supplied as a lyophilized powder in 100 mg single-use vials packaged in cartons of 1 vial (NDC 67211-102-01).
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Vidaza is believed to exert its antineoplastic effects by causing hypomethylation of DNA and direct cytotoxicity on abnormal hematopoietic cells in the bone marrow. The concentration of azacitidine required for maximum inhibition of DNA methylation does not cause major suppression of DNA synthesis. Hypomethylation may restore normal function to genes that are critical for differentiation and proliferation. The cytotoxic effects of azacitidine cause the death of rapidly dividing cells, including cancer cells that are no longer responsive to normal growth control mechanisms. Non-proliferating cells are relatively insensitive to Vidaza.
Non-Clinical Toxicology
Vidaza is contraindicated in patients with a known hypersensitivity to azacitidine or mannitol. Vidaza is also contraindicated in patients with advanced malignant hepatic tumors. (See ).No formal assessments of drug-drug interactions between Vidaza and other agents have been conducted. (See )
Treatment with Vidaza is associated with neutropenia and thrombocytopenia. Complete blood counts should be performed as needed to monitor response and toxicity, but at a minimum, prior to each dosing cycle. After administration of the recommended dosage for the first cycle, dosage for subsequent cycles should be reduced or delayed based on nadir counts and hematologic response as described in .
Safety and effectiveness of Vidaza in patients with MDS and hepatic or renal impairment have not been studied as these patients were excluded from the clinical trials.
Because azacitidine is potentially hepatotoxic in patients with severe pre-existing hepatic impairment, caution is needed in patients with liver disease. Patients with extensive tumor burden due to metastatic disease have been rarely reported to experience progressive hepatic coma and death during azacitidine treatment, especially in such patients with baseline albumin <30 g/L. Azacitidine is contraindicated in patients with advanced malignant hepatic tumors (See ).
Renal abnormalities ranging from elevated serum creatinine to renal failure and death have been reported rarely in patients treated with intravenous azacitidine in combination with other chemotherapeutic agents for non-MDS conditions. In addition, renal tubular acidosis, defined as a fall in serum bicarbonate to <20 mEq/L in association with an alkaline urine and hypokalemia (serum potassium <3 mEq/L) developed in 5 patients with CML treated with azacitidine and etoposide. If unexplained reductions in serum bicarbonate <20 mEq/L or elevations of BUN or serum creatinine occur, the dosage should be reduced or held as described in
Patients with renal impairment should be closely monitored for toxicity since azacitidine and its metabolites are primarily excreted by the kidneys (see section).
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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