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(Dell-ah-ver-deen MEH-sih-late)
Rescriptor
Class: Antiviral

 Action Inhibits replication of HIV-1 infection by interfering with DNA synthesis.

 Indications Treatment of HIV-1 infection in combination with appropriate antiretroviral agents when therapy is warranted.

 Contraindications Standard considerations.

 Route/Dosage

ADULTS & CHILDREN > 16 YR: PO 400 mg tid in combination with appropriate antiretroviral therapy.

 Interactions

Antacids: Antacids reduce absorption of delavirdine. Separate doses by ³ 1 hr. Anticonvulsants (eg, carbamazepine, phenobarbital, phenytoin): Induce hepatic metabolism of delavirdine resulting in decreased plasma concentrations. Astemizole, cisapride, dapsone, ergot derivatives, quinidine, rifabutin, terfenadine, warfarin: Delvirdine may elevate blood levels of these drugs, which may increase the risk of arrhythmias or other potential serious side effects. Benzodiazepines (eg, alprazolam, midazolam, trazazolam): Delvirdine may increase blood levels of these drugs, which may produce extreme sedation and respiratory depression. Clarithromycin: Coadministration may increase blood levels of either delavirdine or clarithromycin. Didanosine: Separate administration of didanosine and delavirdine by ³ 1 hr, because coadministration results in a 20% reduction in systemic exposure of both drugs. Dihydropyridine calcium channel blockers (eg, nifedipine): Delavirdine may elevate blood levels which may increase toxicity. Fluoxetine, ketoconazole: Increased delvirdine plasma concentrations. H2 antagonists (eg, cimetidine): Concurrent use may reduce absorption of delavirdine. Chronic use of these drugs with delavirdine is not recommended. Indinavir: Delavirdine inhibits metabolism of indinavir. Consider indinavir dosage reduction if coadministered with delavirdine. Rifabutin, rifampin: Induce hepatic metabolism of delavirdine resulting in decreased plasma concentrations. These agents should not be coadministered with delavirdine. Saquinavir: Delavirdine inhibits metabolism of saquinavir. Monitor hepatocellular enzymes frequently if coadministered.

 Lab Test Interferences None well documented.

 Adverse Reactions

CV: Fatigue; tachycardia; bradycardia; pallor; palpitation; postural hypotension; syncope; vasodilation. CNS: Lethargy; headache; migraine; abnormal coordination; agitation; amnesia; anxiety; change in dreams; cognitive impairment; confusion; depression; disorientation; dizziness; emotional lability; hallucination; hyperesthesia; impaired concentration; insomnia; manic symptoms; nervousness; neuropathy; nightmares; paranoid symptoms; paresthesia; restlessness; somnolence; tingling; tremor; vertigo. DERM: Rash; pruritis; angioedema; dermal leukocytoblastic vasculitis; dermatitis; desquamation; sweating; dry skin; erythema; erythema multiforme; folliculitis; fungal dermatitis; alopecia; nail disorder; petechial rash; seborrhea; skin nodule; Stevens-Johnson syndrome; urticaria; vesiculobullous rash; bruise; ecchymosis; petechia; purpura. EENT: Nystagmus; blepharitis; conjunctivitis; diplopia; dry eyes; photophobia; tinnitus; ear pain; esophagitis; laryngismus; pharyngitis; sinusitis; rhinitis; epistaxis. GI: Nausea; diarrhea; vomiting; abdominal cramps; distention; pain; lip edema; anorexia; aphthous stomatitis; bloody stool; colitis; constipation; decreased appetite; diverticulitis; duodenitis; dry mouth; dyspepsia; dysphagia; enteritis; fecal incontinence; flatulence; gagging; gastritis; gastroesophageal reflux; GI bleeding; gingivitis; gum hemorrhage; increased appetite; increased saliva; thirst; mouth ulcer; pancreatitis; rectal disorder; sialadenitis; stomatitis; tongue edema; ulceration; taste perversion. GU: Decreased libido; breast enlargement; kidney calculi; epididymitis; hematuria; hemospermia; impotence; kidney pain; metrorrhagia; nocturia; polyuria; proteinuria; vaginal moniliasis. HEMA: Anemia; eosinophilia; granulocytosis; neutropenia; pancytopenia; prolonged partial thromboplastin; spleen disorder; thrombocytopenia. HEPA Increased ALT; increased AST; hepatitis. META: Bilirubinemia; hyperkalemia; hyperuricemia; hypocalcemia; hyponatremia; hypophosphatemia; increased gamma glutamyl transpeptidase; increased lipase; increase serum alkaline phosphatase; increased serum amylase; increased serum creatinine phosphokinase; increased serum creatinine; peripheral edema. RESP: Upper respiratory infection; bronchitis; chest congestion; cough; dyspnea. OTHER: Asthenia; back pain; chest pain; flank pain; chills; edema; fever; flu-like syndrome; lethargy; weakness; malaise; neck rigidity; sebaceous and epidermal cysts; muscle cramps; paralysis; weight increase or decrease; arthralgia; arthritis; bone disorder; bone pain; myalgia; tendon disorder; tenosynovitis; tetany.

 Precautions

Pregnancy: Category C. Lactation: Undetermined. HIV infected mothers should not breastfeed their infants. Children: Safety and efficacy in children < 16 yr not established. Hepatic function impairment: Delavirdine is metabolized primarily by the liver. Use with caution in patients with impaired hepatic function. Resistance: Resistant virus emerges rapidly when delavirdine is administered as monotherapy. Always use in combination with appropriate antiretroviral therapy. Rash: Rash is the most common side effect and may range from minor to severe.

PATIENT CARE CONSIDERATIONS

 Administration/Storage

  • Administer with or without food.
  • Administer with an acidic beverage (eg, orange or cranberry juice) if patient has achlorhydria.
  • May disperse tablets in water prior to administration. Add tablets to ³ 3 oz of water. Stir until uniformly dispersed and administer promptly. Rinse glass and have patient swallow the rinse to ensure the entire dose is consumed.
  • If patient also takes antacids, separate doses by ³ 1 hr.
  • Store at controlled room temperature in tightly closed container. Protect from high humidity.

 Assessment/Interventions

  • Obtain patient history, including drug history and any known allergies. Note hepatic function impairment.
  • Ensure that patient is also receiving antiretroviral therapy concurrently.
  • If used in combination with saquinavir, ensure that hepatocellular enzymes are monitored frequently.
  • Monitor patient for development of severe rash or rash accompanied by symptoms of fever, blistering, oral lesions, conjunctivitis, swelling or muscle or joint aches. If any occur discontinue therapy and notify physician.

 Patient/Family Education

  • Advise patient to take medication with or without food exactly as prescribed.
  • If patient has difficulty swallowing tablets, instruct patient in proper method for dispersing tablets in water.
  • Advise patients with achlorhydria to take each dose with an acidic beverage (eg, orange or cranberry juice).
  • Advise patients who are also taking antacids or didanosine to separate doses by ³ 1 hr.
  • Warn patient not to alter dose or discontinue the medication without consulting their healthcare provider.
  • Advise patient that if a dose is missed, it should be taken as soon as possible and then return to their normal dose. However, if a dose is skipped, the patient should NOT double the next dose.
  • Instruct patient not to take any other medications, (including otc) without checking with their healthcare provider. This medication interacts with a wide range of medications.
  • Explain that the patient will be required to have frequent follow-up blood and urine tests during the course of treatment and to keep appointments.
  • Inform patient that this medication is NOT a cure for HIV infection and they may continue to acquire secondary illnesses associated with the disease.
  • Emphasize to patient, family and significant others that this medication does NOT reduce the risk of transmitting HIV to others through sexual contact or blood contamination.
  • Inform patient that rash is the most common adverse effect and advise patient to promptly notify their physician should rash occur.
  • Advise patient to discontinue therapy and contact their physician immediately should any of the following occur: severe rash; rash accompanied by fever, blistering, oral lesions, conjunctivitis, swelling or muscle or joint aches.
  • Inform patient to report serious or bothersome side effects to their healthcare provider.
  • Explain that the long-term effects of this medication are not known at this time.

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