"The U.S. Food and Drug Administration today approved Tivicay (dolutegravir), a new drug to treat HIV-1 infection.
Tivicay is an integrase strand transfer inhibitor that interferes with one of the enzymes necessary for HIV to multiply. "...
Hivid Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Hivid (zalcitabine) is an antiviral medication used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). It is not a cure for HIV or AIDS. The brand name of this medication is discontinued, but generic versions may be available. Common side effects include nausea, vomiting, stomach pain, diarrhea, constipation, headache, tired feeling, skin rash, or changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk).
The recommended regimen is one 0.750 mg tablet of Hivid orally every 8 hours (2.25 mg Hivid total daily dose) in combination with other antiretroviral agents. Hivid may interact with cimetidine, foscarnet, nitrofurantoin, probenecid, amphotericin B, antibiotics, or other drugs that can affect the pancreas, such as asparaginase, azathioprine, estrogens, furosemide, methyldopa, pentamidine, sulindac, valproic acid, diuretics, or sulfa drugs. Tell your doctor all medications and supplements you use. Hivid may be harmful to a fetus. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Take all of your HIV medicines as directed to control your infection while you are pregnant. Your name may need to be listed on an antiviral pregnancy registry when you start using Hivid to track the outcome of the pregnancy and delivery to evaluate whether the drug had any effect on the baby. Because breast milk can transmit HIV, do not breastfeed.
Our Hivid (zalcitabine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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.
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Hivid Overview - Patient Information: Side Effects
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Hivid (Zalcitabine)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Hivid FDA Prescribing Information: Side Effects
Tables 2 and 3 summarize the clinical adverse events and laboratory abnormalities, respectively, that occurred in ≥ 1% of patients in the comparative monotherapy trial (CPCRA 002) of HIVID (zalcitabine) vs didanosine (ddI), and the comparative combination trial (ACTG 175) of zidovudine (ZDV) monotherapy vs HIVID (zalcitabine) and zidovudine combination therapy, respectively. Other studies have found a higher or lower incidence of adverse experiences depending upon disease status, generally being lower in patients with less advanced disease.
Table 2. Percentage of Patients With Clinical Adverse Experience
≥ Grade 3*† in ≥ 1% of Patients Receiving HIVID (zalcitabine)
|CPCRA 002* ZDV Intolerantor Failure||ACTG 175‡ ZDV Naive/Experienced|
|HIVID 0.750 mg q8h
|ddI 250 mg q12h
|ZDV 200 mg q8h
|HIVID + ZDV 0.750 mg q8h + 200 mg q8h
|Body System/Adverse Event|
|Abnormal Hepatic Function||8.9||7.0|||||||||
|Metabolic and Nutrition|
|* Grade 2 Adverse Events possibly or probably
related to treatment or unassessable were included if study drug dosage
was changed or interrupted.
† Grade 3 severity: event possible hospitalization.
Grade 4 severity: completely disabling, unable to care for self, requiring active medical intervention, probable hospitalization or hospice care.
‡ All relationships.
§ Adverse experiences were combined to form this category.
|| See Table 3.
¶ CPCRA 002 included patients who were dose-adjusted for Grade 2 events; ACTG 175 required dose adjustment for Grade 2 peripheral neuropathy but recorded only Grade 3 events.
Table 3. Percentage of Patients With Laboratory Abnormalities
- Protocol Grade 3/4
|CPCRA 002* ZDV Intolerant or Failure||ACTG 175 ZDV Naive/Experienced|
|HIVID 0.750 mg q8h
|ddI 250 mg q12h
|ZDV 200 mg q8h
|HIVID (zalcitabine) +ZDV
0.750 mg q8h+200 mg q8h
|Anemia (<7.5 gm/dL)||8.4||7.4||1.8||3.1|
|Leukopenia (<1500 cells/mm3)||13.1||9.6||N/A||N/A|
|Eosinophilia (>1000 cells/mm3 or 25%)||2.5||1.7||N/A||N/A|
|Neutropenia (<750 cells/mm3)||16.9||11.7||1.9||4.2|
|Thrombocytopenia (<50,000 cells/mm3)||1.3||4.8||1.1||1.8|
|CPK Elevation* (>4 x ULN)||0.8||0.0||5.8||5.7|
|ALT (SGPT) (>5 x ULN)||N/A||N/A||3.6||5.0|
|AST (SGOT) (>5 x ULN)||7.6||5.7||2.9||4.1|
|Bilirubin (>2.5 x ULN)||0.8||0.9||0.5||1.0|
|GGT (>5 x ULN)||N/A||N/A||0.5||1.0|
|Amylase (>2 x ULN)||5.1||3.9||1.0||1.5|
|Hyperglycemia* (>250 mg/dL)||0.0||1.7||0.8||2.0|
|*Grade 3 or higher reported for CPCRA 002.
N/A Not available.
Additional clinical adverse experiences associated with HIVID (zalcitabine) that occurred in < 1% of patients in CPCRA 002 (at least possibly related, Grade 3 or higher), ACTG 175 (any relationship, Grade 3/4) or in other clinical studies are listed below by body system. Several of these events occurred in slightly higher rates in other studies. The incidence of adverse experiences varied in different studies, generally being lower in patients with less-advanced disease.
Body as a Whole: abnormal weight loss, asthenia, cachexia, chest tightness or pain, chills, cutaneous/allergic reaction, debilitation, difficulty moving, dry eyes/mouth, edema, facial pain or swelling, flank pain, flushing, increased sweating, lymphadenopathy, hypersensitivity reactions (see WARNINGS), malaise, night sweats, pain, pelvic/groin pain, rigors, redistribution/accumulation of body fat (see PRECAUTIONS: Fat Redistribution).
Cardiovascular: abnormal cardiac movement, arrhythmia, atrial fibrillation, cardiac failure, cardiac dysrhythmias, cardiomyopathy, heart racing, hypertension, palpitation, subarachnoid hemorrhage, syncope, tachycardia, ventricular ectopy.
Endocrine/Metabolic: abnormal triglycerides, abnormal lipase, altered serum glucose, decreased bicarbonate, diabetes mellitus, glycosuria, gout, hot flushes, hypercalcemia, hyperkalemia, hyperlipemia, hypernatremia, hyperuricemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, hypophosphatemia, increased nonprotein nitrogen, lactic acidosis.
Gastrointestinal:abdominal bloating or cramps, acute pancreatitis, anal/rectal pain, anorexia, bleeding gums, bloody or black stools, colitis, dental abscess, dry mouth, dyspepsia, dysphagia, enlarged abdomen, epigastric pain, eructation, esophageal pain, esophageal ulcers, esophagitis, flatulence, gagging with pills, gastritis, gastrointestinal hemorrhage, gingivitis, glossitis, gum disorder, heartburn, hemorrhagic pancreatitis, hemorrhoids, increased saliva, left quadrant pain, melena, mouth lesion, odynophagia, painful sore gums, painful swallowing, pancreatitis, rectal hemorrhage, rectal mass, rectal ulcers, salivary gland enlargement, sore tongue, sore throat, tongue disorder, tongue ulcer, toothache, unformed/loose stools, vomiting.
Hematologic: absolute neutrophil count alteration, anemia, epistaxis, decreased hematocrit, granulocytosis, hemoglobinemia, leukopenia, neutrophilia, platelet alteration, purpura, thrombus, unspecified hematologic toxicity, white blood cell alteration.
Musculoskeletal: arthralgia, arthritis, arthropathy, arthrosis, back pain, backache, bone pains/aches, bursitis, cold extremities, extremity pain, joint inflammation, leg cramps, muscle aches, muscle weakness, muscle disorder, muscle stiffness, muscle cramps, myalgia, myopathy, myositis, neck pain, rib pain, stiff neck.
Neurological: abnormal coordination, aphasia, ataxia, Bell's palsy, confusion, decreased concentration, decreased neurological function, disequilibrium, dizziness, dysphonia, facial nerve palsy, focal motor seizures, grand mal seizure, hyperkinesia, hypertonia, hypokinesia, memory loss, migraine, neuralgia, neuritis, paralysis, seizures, speech disorder, status epilepticus, stupor, tremor, twitch, vertigo.
Psychological:acute psychotic disorder, acute stress reaction, agitation, amnesia, anxiety, confusion, decreased motivation, decreased sexual desire, depersonalization, emotional lability, euphoria, hallucination, impaired concentration, insomnia, manic reaction, mood swings, nervousness, paranoid state, somnolence, suicide attempt, dementia.
Respiratory: acute nasopharyngitis, chest congestion, coughing, cyanosis, difficulty breathing, dry nasal mucosa, dyspnea, flu-like symptoms, hemoptysis, nasal discharge, pharyngitis, rales/rhonchi, respiratory distress, sinus congestion, sinus pain, sinusitis, wheezing.
Skin: acne, alopecia, bullous eruptions, carbuncle/furuncle, cellulitis, cold sore, dermatitis, dry skin, dry rash desquamation, erythematous rash, exfoliative dermatitis, finger inflammation, follicular rash, impetigo, infection, itchy rash, lip blisters/lesions, macular/papular rash, maculopapular rash, moniliasis, mucocutaneous/skin disorder, nail disorder, photosensitivity reaction, pruritic disorder, pruritus, skin disorder, skin lesions, skin fissure, skin ulcer, urticaria.
Special Senses: abnormal vision, blurred vision, burning eyes, decreased taste, decreased vision, ear pain/problem, ear blockage, eye abnormality, eye inflammation, eye itching, eye pain, eye irritation, eye redness, eye hemorrhage, fluid in ears, hearing loss, increased tears, loss of taste, mucopurulent conjunctivitis, parosmia, photophobia, smell dysfunction, taste perversion, tinnitus, unequal-sized pupils, xerophthalmia, yellow sclera.
Urogenital: abnormal renal function, acute renal failure, albuminuria, bladder pain, dysuria, frequent urination, genital lesion/ulcer, increased blood urea nitrogen, increased creatinine, micturition frequency, nocturia, painful penis sore, pain on urination, penile edema, polyuria, renal cyst, renal calculus, testicular swelling, toxic nephropathy, urinary retention, vaginal itch, vaginal ulcer, vaginal pain, vaginal/cervix disorder, vaginal discharge.
Read the entire FDA prescribing information for Hivid (Zalcitabine)
Additional Hivid Information
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