in-DIN-a-veer

• HIV infection (with other antiretrovirals).

Unlabeled Use:

• Prevention of HIV infection after known exposure (with other antiretrovirals).

• Inhibits the action of HIV protease and prevents the cleavage of viral polyproteins.

• Slowing of the progression of HIV infection and its sequelae.

Absorption: Rapidly absorbed after oral administration.

Distribution: Unknown.

Metabolism/Excretion: Mostly metabolized by the liver; <20% excreted unchanged by the kidneys.

Half-life: 1.8 hr.

Contraindicated in:

• Hypersensitivity
• Dehydration
• Concurrent amiodarone, alfuzosin, alprazolam, ergot derivatives, lovastatin, midazolam (PO), pimozide, lurasidone, rifampin, simvastatin, triazolam, or sildenafil (Revatio).

Use Cautiously in:

• Hepatic impairment (dose ↓ recommended in moderate to severe hepatic insufficiency caused by cirrhosis)
• Hemophilia (↑ risk of bleeding)
• Diabetes mellitus
• Lactation: Pedi: Safety not established; breastfeeding not recommended in HIV-infected patients.

GI: abdominal pain, acid regurgitation, altered taste, asymptomatic hyperbilirubinemia, diarrhea, nausea, vomiting.

GU: nephrolithiasis.

Endo: hyperglycemia.

F and E: KETOACIDOSIS.

MS: back pain, flank pain.

Neuro: dizziness, drowsiness, fatigue, headache, insomnia, weakness.

Misc: immune reconstitution syndrome, redistribution of body fat.

Drug-Drug:

• ↑blood levels and risk of toxicity fromamiodarone, alprazolam, ergot derivatives (dihydroergotamine, ergotamine, lovastatin, methylergonovine), midazolam (PO), pimozide, lurasidone, simvastatin, triazolam, alfuzosin, or sildenafil (Revatio); concurrent use is contraindicated.
• Rifampin↓ blood levels; concurrent use should be avoided.
• ↑risk of myopathy with atorvastatin or rosuvastatin; use lowest possible dose of statin.
• ↑risk of hyperbilirubinemia with atazanavir ; concurrent use is not recommended.
• ↑blood levels of rifabutin(↓ dose of rifabutin by 50%) and hormonal contraceptives.
• Rifabutin, carbamazepine, phenytoin, phenobarbital, venlafaxine, nevirapine, and efavirenz↓ indinavir levels; if concurrent rifabutin or efavirenz therapy is necessary, ↑ indinavir dose to 1000 mg every 8 hr; also ↓ dose of rifabutin by 50%.
• Blood levels are ↑ by ketoconazole, itraconazole, and delavirdine (↓ indinavir dose to 600 mg every 8 hr).
• ↑blood levels of saquinavir, lidocaine, quinidine, fluticasone, cyclosporine, tacrolimus, sirolimus, trazodone, and calcium channel blockers.
• Use with clarithromycin↑ clarithromycin levels and ↓ indinavir levels.
• Blood levels are ↑ by nelfinavir and ritonavir; use with ritonavir may ↑ risk of nephrolithiasis.
• Alters absorption of didanosine; administer 1 hr apart.
• May ↑ blood levels and effects of sildenafil, vardenafil or tadalafil; sildenafil dose should not exceed 25 mg in 48–hr period; tadalafil dose should not exceed 10 mg in 72–hr period; vardenafil dose should not exceed 2.5 mg in 24–hr period.
• May ↑ risk of adverse effects with salmeterol; concurrent use not recommended.
• May ↑ bosentan levels; initiate bosentan at 62.5 mg once daily or every other day.
• May ↑ tadalafil (Adcirca) levels; initiate tadalafil (Adcirca) at 20 mg once daily.
• May ↑ colchicine levels; ↓ dose of colchicine; do not administer colchicine if patients have renal or hepatic impairment.
• May ↑ quetiapine levels; ↓ quetiapine dose to 1/6 of current dose

Drug-Natural Products:

• St. John’s wort significantly ↓ blood levels; concurrent use is contraindicated.

Drug-Food:

• High-fat or high-protein meals↓ absorption.

• PO (Adults): 800 mg every 8 hr.

• Do not confuse indinavir with Denavir (penciclovir).
• PO: Administer with water 1 hr before or 2 hr after a meal. May be taken with other liquids (skim milk, juice, coffee, tea). Avoid high-fat, high-protein meals within 2 hr of indinavir.
  • Patients on concurrent didanosine therapy should take didanosine and indinavir at least 1 hr apart.

Crixivan

Therapeutic Classification: antiretrovirals

Pharmacologic Classification: protease inhibitors

• Capsules: 200 mg;

(blood levels)

• Assess for change in severity of symptoms of HIV infection and for symptoms of opportunistic infections throughout therapy.

• Monitor viral load and CD4 cell count periodically during therapy.
  • May cause hyperglycemia.
  • May cause ↑ serum AST, ALT, total bilirubin, and amylase concentrations.

• Risk for infection (Indications).
• Noncompliance (Patient/Family Teaching).

• Emphasize the importance of taking indinavir as directed, at evenly spaced times throughout day. Do not take more than prescribed amount and do not stop taking without consulting health care professional. Take missed doses as soon as remembered if within 2 hrs of missed dose. If more than 2 hrs from missed dose, skip dose and take next scheduled dose; do not double doses. Advise patient to read Patient Information before starting therapy and with each Rx refill in case of changes.
• Instruct patient that indinavir should not be shared with others.
• Instruct patient to store indinavir in original container with desiccant in bottle; indinavir is sensitive to moisture.
• Indinavir may cause kidney stones. Advise patient to drink at least 1.5 L of water each day. Kidney stones may require 1–3 day interruption of therapy.
• Inform patient that indinavir may cause hyperglycemia. Advise patient to notify health care professional if increased thirst or hunger; unexplained weight loss; increased urination; fatigue; or dry, itchy skin occurs.
• Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications, especially St. John's Wort. If taking sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra) with indinavir may increase risk of side effects (low BP, visual changes, and penile erection lasting more than 4 hrs). Notify health care professional immediately if erection lasts more than 4 hrs.
• Advise patients concurrently taking didanosine that both medications must be taken on an empty stomach, 1 hr apart.
• Inform patient that indinavir does not cure AIDS and does not reduce the risk of transmission of HIV to others through sexual contact or blood contamination. Caution patient to use a condom and avoid sharing needles or donating blood to prevent spreading HIV to others.
• May cause drowsiness and dizziness. Advise patient to avoid driving and other activities requiring alertness until response to medication is known.
• Inform patient that redistribution and accumulation of body fat may occur, causing central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, breast enlargement, and cushingoid appearance. The cause and long-term effects are not known.
• Advise female patients to notify health care professional if pregnancy is planned or suspected and to avoid breastfeeding.
• Emphasize the importance of regular follow-up exams and blood counts to determine progress and monitor for side effects.

• Delayed progression of AIDS and decreased opportunistic infections in patients with HIV.
• Improved CD4 cell count and decrease in viral load.

NDC Code^*

• 0006- Merck Sharp and Dohme Corp.
  • 0006-0571- CRIXIVAN
    • 0006-0571-43- 360 CAPSULE in 1 BOTTLE (0006-0571-43)

• 0006- Merck Sharp and Dohme Corp.
  • 0006-0573- CRIXIVAN
    • 0006-0573-62- 180 CAPSULE in 1 BOTTLE (0006-0573-62)