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RESCRIPTOR
Overview
What is RESCRIPTOR?
RESCRIPTOR tablets contain delavirdine mesylate, a synthetic non-nucleoside reverse transcriptase inhibitor (NNRTI) of the human immunodeficiency virus type 1 (HIV-1). The chemical name of delavirdine mesylate is piperazine, 1-[3-[(1-methyl-ethyl)amino]-2- pyridinyl]-4-[[5-[(methylsulfonyl)amino]-1H-indol-2-yl]carbonyl]-, monomethanesulfonate. Its molecular formula is CHNOS•CHOS, and its molecular weight is 552.68. The structural formula is:
Delavirdine mesylate is an odorless white-to-tan crystalline powder. The aqueous solubility of delavirdine free base at 23°C is 2,942 mcg/mL at pH 1.0, 295 mcg/mL at pH 2.0, and 0.81 mcg/mL at pH 7.4.
Each RESCRIPTOR tablet, for oral administration, contains 100 or 200 mg of delavirdine mesylate (henceforth referred to as delavirdine). Inactive ingredients consist of carnauba wax, colloidal silicon dioxide, croscarmellose sodium, lactose, magnesium stearate, and microcrystalline cellulose. In addition, the 100-mg tablet contains Opadry White YS-1-7000-E and the 200-mg tablet contains hypromellose and Opadry White YS-1-18202-A.
What does RESCRIPTOR look like?
What are the available doses of RESCRIPTOR?
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What should I talk to my health care provider before I take RESCRIPTOR?
Sorry No records found
How should I use RESCRIPTOR?
RESCRIPTOR tablets are indicated for the treatment of HIV-1 infection in combination with at least 2 other active antiretroviral agents when therapy is warranted.
The following should be considered before initiating therapy with RESCRIPTOR in treatment-naive patients. There are insufficient data directly comparing antiretroviral regimens containing RESCRIPTOR with currently preferred 3-drug regimens for initial treatment of HIV. In studies comparing regimens consisting of 2 nucleoside reverse transcriptase inhibitors (NRTIs) (currently considered suboptimal) to RESCRIPTOR plus 2 NRTIs, the proportion of patients receiving the regimen containing RESCRIPTOR who achieved and sustained an HIV-1 RNA level <400 copies/mL over 1 year of therapy was relatively low (see ).
Resistant virus emerges rapidly when RESCRIPTOR is administered as monotherapy. Therefore, RESCRIPTOR should always be administered in combination with other antiretroviral agents.
The recommended dosage for RESCRIPTOR tablets is 400 mg (four 100-mg or two 200-mg tablets) 3 times daily. RESCRIPTOR should be used in combination with other antiretroviral therapy. The complete prescribing information for other antiretroviral agents should be consulted for information on dosage and administration.
The 100-mg RESCRIPTOR tablets may be dispersed in water prior to consumption. To prepare a dispersion, add four 100-mg RESCRIPTOR tablets to at least 3 ounces of water, allow to stand for a few minutes, and then stir until a uniform dispersion occurs (see : ). The dispersion should be consumed promptly. The glass should be rinsed with water and the rinse swallowed to insure the entire dose is consumed. Note: The 200-mg tablets are approximately one-third smaller in size than the 100-mg tablets.
RESCRIPTOR tablets may be administered with or without food (see : ). Patients with achlorhydria should take RESCRIPTOR with an acidic beverage (e.g., orange or cranberry juice). However, the effect of an acidic beverage on the absorption of delavirdine in patients with achlorhydria has not been investigated.
Patients taking both RESCRIPTOR and antacids should be advised to take them at least 1 hour apart.
What interacts with RESCRIPTOR?
RESCRIPTOR tablets are contraindicated in patients with known hypersensitivity to any of its ingredients. Coadministration of RESCRIPTOR is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events. These drugs are listed in .
What are the warnings of RESCRIPTOR?
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Drug Interactions:
Because delavirdine may inhibit the metabolism of many different drugs (e.g., antiarrhythmics, calcium channel blockers, sedative hypnotics, and others), . In addition, some drugs may markedly reduce delavirdine plasma concentrations, resulting in suboptimal antiviral activity and subsequent emergence of drug resistance. All prescribers should become familiar with the following tables in this package insert:
. Additional details on drug interactions can be found in Tables and under the section.
Concomitant use of lovastatin or simvastatin with RESCRIPTOR is not recommended. Caution should be exercised if RESCRIPTOR is used concurrently with other HMG-CoA reductase inhibitors that are also metabolized by the CYP3A4 pathway (e.g., atorvastatin or cerivastatin). The risk of myopathy including rhabdomyolysis may be increased when RESCRIPTOR is used in combination with these drugs.
Particular caution should be used when prescribing sildenafil in patients receiving RESCRIPTOR. Coadministration of sildenafil with RESCRIPTOR is expected to substantially increase sildenafil concentrations and may result in an increase in sildenafil-associated adverse events, including hypotension, visual changes, and priapism (see : and , and the complete prescribing information for sildenafil).
Concomitant use of St. John’s wort () or St. John’s wort-containing products and RESCRIPTOR is not recommended. Coadministration of St. John’s wort with NNRTIs, including RESCRIPTOR, is expected to substantially decrease NNRTI concentrations and may result in suboptimal levels of RESCRIPTOR and lead to loss of virologic response and possible resistance to RESCRIPTOR or to the class of NNRTIs.
What are the precautions of RESCRIPTOR?
Sorry No Records found
What are the side effects of RESCRIPTOR?
The safety of RESCRIPTOR tablets alone and in combination with other therapies has been studied in approximately 6,000 patients receiving RESCRIPTOR. The majority of adverse events were of mild or moderate (i.e., ACTG Grade 1 or 2) intensity. The most frequently reported drug-related adverse event (i.e., events considered by the investigator to be related to the blinded study medication or events with an unknown or missing causal relationship to the blinded medication) among patients receiving RESCRIPTOR was skin rash (see and : ).
Adverse events of moderate to severe intensity reported by at least 5% of evaluable patients in any treatment group in the pivotal trials, which includes patients receiving RESCRIPTOR in combination with zidovudine and/or lamivudine in Study 21 Part II for up to 98 weeks and in combination with zidovudine and either lamivudine, didanosine, or zalcitabine in Study 13C for up to 72 weeks are summarized in .
| Array | |||||
| Percent of Patients with: | Description of Rash Grade | ||||
| Grade 1 rash | Erythema, pruritus | 69 (16.7%) | 35 (11.9%) | ||
| Grade 2 rash | Diffuse maculopapular rash, dry desquamation | 59 (14.3%) | 17 (5.8%) | ||
| Grade 3 rash | Vesiculation, moist desquamation, ulceration | 18 (4.4%) | 0 (0.0%) | ||
| Grade 4 rash | Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, necrosis requiring surgery, exfoliative dermatitis | 0 (0.0%) | 0 (0.0%) | ||
| Rash of any grade | 146 (35.4%) | 52 (17.6%) | |||
| Treatment discontinuation as a result of rash | 13 (3.2%) | 1 (0.3%) | |||
| a | |||||
| Study 21 Part II | Study 13C | ||||
| Adverse Events | |||||
| Abdominal pain, generalized | 2.4 (3) | 3.3 (4) | 5.0 (6) | 1.7 (3) | 2.4 (4) |
| Asthenia/fatigue | 16.3 (20) | 15.4 (19) | 16.0 (19) | 8.1 (14) | 5.3 (9) |
| Fever | 2.4 (3) | 1.6 (2) | 3.4 (4) | 6.4 (11) | 7.1 (12) |
| Flu syndrome | 4.9 (6) | 7.3 (9) | 5.0 (6) | 5.2 (9) | 2.4 (4) |
| Headache | 14.6 (18) | 12.2 (15) | 16.8 (20) | 12.8 (22) | 11.2 (19) |
| Localized pain | 4.9 (6) | 5.7 (7) | 5.0 (6) | 2.9 (5) | 1.8 (3) |
| Diarrhea | 8.1 (10) | 2.4 (3) | 4.2 (5) | 8.1 (14) | 5.9 (10) |
| Nausea | 17.1 (21) | 20.3 (25) | 16.8 (20) | 9.3 (16) | 14.7 (25) |
| Vomiting | 8.9 (11) | 4.9 (6) | 2.5 (3) | 4.1 (7) | 6.5 (11) |
| Anxiety | 1.6 (2) | 2.4 (3) | 6.7 (8) | 4.1 (7) | 3.5 (6) |
| Depressive symptoms | 6.5 (8) | 4.9 (6) | 12.6 (15) | 3.5 (6) | 5.9 (10) |
| Insomnia | 4.9 (6) | 4.9 (6) | 5.0 (6) | 2.9 (5) | 1.2 (2) |
| Bronchitis | 4.1 (5) | 6.5 (8) | 6.7 (8) | 3.5 (6) | 3.5 (6) |
| Cough | 9.8 (12) | 4.1 (5) | 5.0 (6) | 5.2 (9) | 3.5 (6) |
| Pharyngitis | 6.5 (8) | 1.6 (2) | 5.0 (6) | 4.1 (7) | 3.5 (6) |
| Sinusitis | 8.9 (11) | 7.3 (9) | 5.0 (6) | 2.3 (4) | 1.2 (2) |
| Upper respiratory infection | 11.4 (14) | 6.5 (8) | 7.6 (9) | 8.7 (15) | 4.7 (8) |
| Rashes | 3.3 (4) | 19.5 (24) | 13.4 (16) | 7.6 (13) | 18.8 (32) |
Other Adverse Events in Phase II/III Studies:
Other adverse events that occurred in patients receiving RESCRIPTOR (in combination treatment) in all Phase II and III studies, considered possibly related to treatment, and of at least ACTG Grade 2 in intensity are listed below by body system.
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Postmarketing Experience:
Adverse event terms reported from postmarketing surveillance that were not reported in the Phase II and III trials are presented below.
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Laboratory Abnormalities:
Marked laboratory abnormalities observed in at least 2% of patients during Studies 21 Part II and 13C are summarized in . Marked laboratory abnormalities are defined as any Grade 3 or 4 abnormality found in patients at any time during study.
| Hematology | ||||
| 4.1 | 2.5 | 0.9 | 1.7 | 2.9 |
| 5.7 | 4.9 | 3.4 | 10.4 | 7.6 |
| 0 | 0 | 1.7 | 2.9 | 2.4 |
| 0 | 0.8 | 0 | 5.8 | 2.4 | Chemistry |
| 2.5 | 4.1 | 5.1 | 3.5 | 4.1 |
| 0.8 | 2.5 | 2.6 | 3.5 | 2.9 |
| 1.6 | 2.5 | 3.4 | 3.5 | 2.3 |
| 0.8 | 2.5 | 1.7 | 1.2 | 0 |
| N/A | N/A | N/A | 4.1 | 1.8 |
| 4.1 | 0.8 | 1.7 | 1.2 | 0 |
What should I look out for while using RESCRIPTOR?
RESCRIPTOR tablets are contraindicated in patients with known hypersensitivity to any of its ingredients. Coadministration of RESCRIPTOR is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events. These drugs are listed in .
ALERT: Find out about medicines that should NOT be taken with RESCRIPTOR.
What might happen if I take too much RESCRIPTOR?
Human experience of acute overdose with RESCRIPTOR is limited.
How should I store and handle RESCRIPTOR?
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture.RESCRIPTOR tablets are available as follows: 100-mg: white, capsule-shaped tablets marked with “U 3761”Bottles of 360 tablets - NDC 49702-209-24.200-mg: white, capsule-shaped tablets marked with “RES200”Bottles of 180 tablets - NDC 49702-225-17. Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Keep container tightly closed. Protect from high humidity. RESCRIPTOR tablets are available as follows: 100-mg: white, capsule-shaped tablets marked with “U 3761”Bottles of 360 tablets - NDC 49702-209-24.200-mg: white, capsule-shaped tablets marked with “RES200”Bottles of 180 tablets - NDC 49702-225-17. Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Keep container tightly closed. Protect from high humidity. RESCRIPTOR tablets are available as follows: 100-mg: white, capsule-shaped tablets marked with “U 3761”Bottles of 360 tablets - NDC 49702-209-24.200-mg: white, capsule-shaped tablets marked with “RES200”Bottles of 180 tablets - NDC 49702-225-17. Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Keep container tightly closed. Protect from high humidity. RESCRIPTOR tablets are available as follows: 100-mg: white, capsule-shaped tablets marked with “U 3761”Bottles of 360 tablets - NDC 49702-209-24.200-mg: white, capsule-shaped tablets marked with “RES200”Bottles of 180 tablets - NDC 49702-225-17. Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Keep container tightly closed. Protect from high humidity. RESCRIPTOR tablets are available as follows: 100-mg: white, capsule-shaped tablets marked with “U 3761”Bottles of 360 tablets - NDC 49702-209-24.200-mg: white, capsule-shaped tablets marked with “RES200”Bottles of 180 tablets - NDC 49702-225-17. Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Keep container tightly closed. Protect from high humidity. RESCRIPTOR tablets are available as follows: 100-mg: white, capsule-shaped tablets marked with “U 3761”Bottles of 360 tablets - NDC 49702-209-24.200-mg: white, capsule-shaped tablets marked with “RES200”Bottles of 180 tablets - NDC 49702-225-17. Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Keep container tightly closed. Protect from high humidity.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Absorption and Bioavailability:
Delavirdine may be administered with or without food. In a multiple-dose, crossover study, delavirdine was administered every 8 hours with food or every 8 hours, 1 hour before or 2 hours after a meal (n = 13, HIV-1–infected patients). Patients remained on their typical diet throughout the study; meal content was not standardized. When multiple doses of delavirdine were administered with food, geometric mean C was reduced by approximately 25%, but AUC and C were not altered.
Distribution:
Metabolism and Elimination:
In vitro and in vivo studies have shown that delavirdine reduces CYP3A activity and inhibits its own metabolism. In vitro studies have also shown that delavirdine reduces CYP2C9, CYP2D6, and CYP2C19 activity. Inhibition of hepatic CYP3A activity by delavirdine is reversible within 1 week after discontinuation of drug.
Non-Clinical Toxicology
RESCRIPTOR tablets are contraindicated in patients with known hypersensitivity to any of its ingredients. Coadministration of RESCRIPTOR is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events. These drugs are listed in .ALERT: Find out about medicines that should NOT be taken with RESCRIPTOR.
(See also , , and : .)
Delavirdine is an inhibitor of CYP3A isoform and other CYP isoforms to a lesser extent including CYP2C9, CYP2D6, and CYP2C19. Coadministration of RESCRIPTOR and drugs primarily metabolized by CYP3A (e.g., HMG-CoA reductase inhibitors and sildenafil) may result in increased plasma concentrations of the coadministered drug that could increase or prolong both its therapeutic or adverse effects.
Delavirdine is metabolized primarily by CYP3A, but in vitro data suggest that delavirdine may also be metabolized by CYP2D6. Coadministration of RESCRIPTOR and drugs that induce CYP3A, such as rifampin, may decrease delavirdine plasma concentrations and reduce its therapeutic effect. Coadministration of RESCRIPTOR and drugs that inhibit CYP3A may increase delavirdine plasma concentrations.
Delavirdine is metabolized primarily by the liver. Therefore, caution should be exercised when administering RESCRIPTOR tablets to patients with impaired hepatic function.
The safety of RESCRIPTOR tablets alone and in combination with other therapies has been studied in approximately 6,000 patients receiving RESCRIPTOR. The majority of adverse events were of mild or moderate (i.e., ACTG Grade 1 or 2) intensity. The most frequently reported drug-related adverse event (i.e., events considered by the investigator to be related to the blinded study medication or events with an unknown or missing causal relationship to the blinded medication) among patients receiving RESCRIPTOR was skin rash (see and : ).
Adverse events of moderate to severe intensity reported by at least 5% of evaluable patients in any treatment group in the pivotal trials, which includes patients receiving RESCRIPTOR in combination with zidovudine and/or lamivudine in Study 21 Part II for up to 98 weeks and in combination with zidovudine and either lamivudine, didanosine, or zalcitabine in Study 13C for up to 72 weeks are summarized in .
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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