Rescriptor
- Generic Name: delavirdine mesylate
- Brand Name: Rescriptor
- Drug Class: HIV, NNRTIs
Rescriptor (Delavirdine Mesylate) side effects drug center
Rescriptor Side Effects Center
Rescriptor (delavirdine mesylate) is an antiviral medication used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Rescriptor is not a cure for HIV or AIDS. Common side effects of Rescriptor include:
- nausea
- diarrhea
- headache
- tiredness
- changes in the shape and location of body fat (especially in your arms, legs, face, neck, breasts, and waist)
- worsening of a previous medical condition (such as an old infection)
- itching
- rash, or
- cold symptoms (stuffy nose, sneezing, or sore throat).
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. Rescriptor may interact with sildenafil, St. John's wort, blood thinners, cholesterol medications, antibiotics, heart or blood pressure medications, heart rhythm medicines, medications to prevent organ transplant rejection, other HIV medicines, sedatives, seizure medications, steroids, or stomach medications. Tell your doctor all medications and supplements you use. During pregnancy Rescriptor should be used only if prescribed. HIV medicines are now usually given to pregnant women with HIV. Treatment has been shown to decrease the risk of HIV transmission to the baby. This drug may be part of that treatment; consult your doctor. It is unknown if this drug passes into breast milk. Because breast milk can transmit HIV, do not breastfeed.
Our Rescriptor (delavirdine mesylate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Rescriptor Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using delavirdine and call your doctor at once if you have a severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Delavirdine may increase your risk of certain infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with delavirdine. Tell your doctor if you have:
- signs of a new infection--fever, night sweats, swollen glands, mouth sores, diarrhea, stomach pain, weight loss;
- chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;
- cold sores, sores on your genital or anal area;
- rapid heart rate, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;
- trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or
- swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence, loss of interest in sex.
Common side effects may include:
- mild skin rash;
- nausea, diarrhea;
- feeling tired;
- headache; or
- changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Rescriptor (Delavirdine Mesylate)
Rescriptor Professional Information
SIDE EFFECTS
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 Table 8 and PRECAUTIONS: Skin Rash).
Table 8: Percent of Patients With Treatment-Emergent Rash
in Pivotal Trials (Studies 21 Part II and 13C)a
| Percent of Patients With: | Description of Rash Gradeb | RESCRIPTOR 400 mg t.i.d. (n = 412) |
Control Group Patients (n = 295) |
| 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 Includes events reported regardless of
causality. b ACTG Toxicity Grading System; includes events reported as “rash,” “maculopapular rash,” and “urticaria.” |
|||
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 Table 9.
Table 9: Treatment-Emergent Events Regardless of
Causality, of Moderate-to-Severe or Life-Threatening Intensity Reported by at
Least 5% of Evaluablea Patients in Any Treatment Group
| Adverse Events | Study 21 Part II | Study 13C | |||
| Zidovudine + Lamivudine (n = 123) |
400 mg t.i.d. RESCRIPTOR + Zidovudine (n = 123) |
400 mg t.i.d. RESCRIPTOR + Zidovudine + Lamivudine (n = 119) |
Zidovudine + Didanosine, Zalcitabine, or Lamivudine (n = 172) |
400 mg t.i.d. RESCRIPTOR + Zidovudine + Didanosine, Zalcitabine, or Lamivudine (n = 170) |
|
| % of pts. (n) | % of pts. (n) | % of pts. (n) | % of pts. (n) | % of pts. (n) | |
| Body as a Whole | |||||
| Abdominal pain, generalized | 2.4 (3) | 3.3 (4) | 5.0 (6) | 17 (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) |
| Digestive | |||||
| 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) |
| Nervous | |||||
| 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) |
| Respiratory | |||||
| 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) |
| Skin | |||||
| Rashes | 3.3 (4) | 19.5 (24) | 13.4 (16) | 7.6 (13) | 18.8 (32) |
| aEvaluable patients in Study 21 Part II were those who received at least 1 dose of study medication and returned for at least 1 clinic study visit. Evaluable patients in Study 13C were those who received at least 1 dose of study medication. | |||||
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.
Body as a Whole: Abdominal cramps, abdominal distention, abdominal pain (localized), abscess, allergic reaction, chills, edema (generalized or localized), epidermal cyst, fever, infection, infection viral, lip edema, malaise, Mycobacterium tuberculosis infection, neck rigidity, sebaceous cyst, and redistribution/accumulation of body fat (see PRECAUTIONS: Fat Redistribution).
Cardiovascular System: Abnormal cardiac rate and rhythm, cardiac insufficiency, cardiomyopathy, hypertension, migraine, pallor, peripheral vascular disorder, and postural hypotension.
Digestive System: Anorexia, bloody stool, colitis, constipation, decreased appetite, diarrhea (Clostridium difficile), diverticulitis, dry mouth, dyspepsia, dysphagia, enteritis at all levels, eructation, fecal incontinence, flatulence, gagging, gastroenteritis, gastroesophageal reflux, gastrointestinal bleeding, gastrointestinal disorder, gingivitis, gum hemorrhage, hepatomegaly, increased appetite, increased saliva, increased thirst, jaundice, mouth or tongue inflammation or ulcers, nonspecific hepatitis, oral/enteric moniliasis, pancreatitis, rectal disorder, sialadenitis, tooth abscess, and toothache.
Hemic and Lymphatic System: Adenopathy, bruising, eosinophilia, granulocytosis, leukopenia, pancytopenia, purpura, spleen disorder, thrombocytopenia, and prolonged prothrombin time.
Metabolic and Nutritional Disorders: Alcohol intolerance, amylase increased, bilirubinemia, hyperglycemia, hyperkalemia, hypertriglyceridemia, hyperuricemia, hypocalcemia, hyponatremia, hypophosphatemia, increased AST (SGOT), increased gamma glutamyl transpeptidase, increased lipase, increased serum alkaline phosphatase, increased serum creatinine, and weight increase or decrease.
Musculoskeletal System: Arthralgia or arthritis of single and multiple joints, bone disorder, bone pain, myalgia, tendon disorder, tenosynovitis, tetany, and vertigo.
Nervous System: Abnormal coordination, agitation, amnesia, change in dreams, cognitive impairment, confusion, decreased libido, disorientation, dizziness, emotional lability, euphoria, hallucination, hyperesthesia, hyperreflexia, hypertonia, hypesthesia, impaired concentration, manic symptoms, muscle cramp, nervousness, neuropathy, nystagmus, paralysis, paranoid symptoms, restlessness, sleep cycle disorder, somnolence, tingling, tremor, vertigo, and weakness.
Respiratory System: Chest congestion, dyspnea, epistaxis, hiccups, laryngismus, pneumonia, and rhinitis.
Skin and Appendages: Angioedema, dermal leukocytoclastic vasculitis, dermatitis, desquamation, diaphoresis, discolored skin, dry skin, erythema, erythema multiforme, folliculitis, fungal dermatitis, hair loss, herpes zoster or simplex, nail disorder, petechiae, non-application site pruritus, seborrhea, skin hypertrophy, skin disorder, skin nodule, Stevens-Johnson syndrome, urticaria, vesiculobullous rash, and wart.
Special Senses: Blepharitis, blurred vision, conjunctivitis, diplopia, dry eyes, ear pain, parosmia, otitis media, photophobia, taste perversion, and tinnitus.
Urogenital System: Amenorrhea, breast enlargement, calculi of the kidney, chromaturia, epididymitis, hematuria, hemospermia, impaired urination, impotence, kidney pain, metrorrhagia, nocturia, polyuria, proteinuria, testicular pain, urinary tract infection, and vaginal moniliasis.
Postmarketing Experience
Adverse event terms reported from postmarketing surveillance that were not reported in the Phase II and III trials are presented below.
Digestive System: Hepatic failure.
Hemic and Lymphatic System: Hemolytic anemia.
Musculoskeletal System: Rhabdomyolysis.
Urogenital System: Acute kidney failure.
Laboratory Abnormalities
Marked laboratory abnormalities observed in at least 2% of patients during Studies 21 Part II and 13C are summarized in Table 10. Marked laboratory abnormalities are defined as any Grade 3 or 4 abnormality found in patients at any time during study.
Table 10:Marked Laboratory Abnormalities Reported by ≥ 2%
of Patients
| Adverse Events/Toxicity Limits | Study 21 Part II | Study 13C | |||
| Zidovudine + Lamivudine (n =123) % pts. |
400 mg t.i.d. RESCRIPTOR + Zidovudine (n =123) % pts. |
400 mg t.i.d. RESCRIPTOR + Zidovudine + Lamivudine (n = 119) % pts. |
Zidovudine + Didanosine, Zalcitabine, or Lamivudine (n = 172) % pts. |
400 mg t.i.d. RESCRIPTOR + Zidovudine + Didanosine, Zalcitabine, or Lamivudine (n = 170) % pts. |
|
| Hematology | |||||
| Hemoglobin < 7 mg/dL | 4.1 | 2.5 | 0.9 | 1.7 | 2.9 |
| Neutrophils < 750/mm³ | 5.7 | 4.9 | 3.4 | 10.4 | 7.6 |
| Prothrombin time (PT) > 1.5 x ULN | 0 | 0 | 1.7 | 2.9 | 2.4 |
| Activated partial thromboplastin (APTT) > 2.33 x ULN | 0 | 0.8 | 0 | 5.8 | 2.4 |
| Chemistry | |||||
| Alananine aminotransferase (ALT/SGPT) > 5 x ULN | 2.5 | 4.1 | 5.1 | 3.5 | 4.1 |
| Amylase > 2 x ULN | 0.8 | 2.5 | 2.6 | 3.5 | 2.9 |
| Aspartate aminotransferase (AST/SGOT) > 5 x ULN | 1.6 | 2.5 | 3.4 | 3.5 | 2.3 |
| Bilirubin > 2.5 x ULN | 0.8 | 2.5 | 1.7 | 1.2 | 0 |
| Gamma glutamyl transferase (GGT) > 5 x ULN | N/A | N/A | N/A | 4.1 | 1.8 |
| Glucose (hypo/hyperglycemia) < 40 mg/dL > 250 mg/dL | 4.1 | 0.8 | 1.7 | 1.2 | 0 |
| N/A = not applicable because no predose values were obtained for patients. | |||||
Read the entire FDA prescribing information for Rescriptor (Delavirdine Mesylate)
&Copy; Rescriptor Patient Information is supplied by Cerner Multum, Inc. and Rescriptor Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.