Isentress

— THERAPEUTIC CATEGORIES —
  • Viral infections

Isentress Generic Name & Formulations

General Description

Raltegravir (as potassium) 25mg, 100mg+; chew tabs; scored (+); orange-banana flavor; contains phenylalanine; 400mg; film-coated tabs.

Pharmacological Class

HIV-1 integrase strand transfer inhibitor (INSTI).

How Supplied

Chew tabs, film-coated tabs—60; Susp (pkts)—1, 60 (w. syringes, mixing cups)

Manufacturer

Isentress Indications

Indications

HIV-1 infection, in combination with other antiretrovirals.

Isentress Dosage and Administration

Adult

Film-coated tabs: swallow whole.Treatment-naïve or virologically suppressed on Isentress 400mg twice daily: 1200mg (2 x 600mg) once daily or 400mg twice daily. Treatment-experienced: 400mg twice daily. Avoid dosing before dialysis sessions. Concomitant rifampin: 800mg (2 x 400mg) twice daily.

Children

<4 weeks: use oral susp. Film-coated tabs: swallow whole. ≥4 weeks (<25kg): use other forms; (≥25kg): 400mg twice daily; (≥40kg): treatment-naïve or virologically suppressed on Isentress 400mg twice daily: 1200mg (2 x 600mg) once daily or 400mg twice daily. If unable to swallow, can use chew tabs: (3–<6kg): 25mg twice daily; (6–<10kg): 50mg twice daily; (10–<14kg): 75mg twice daily; (14–<20kg): 100mg twice daily; (20–<25kg): 150mg twice daily; (25–<28kg): 150mg twice daily; (28–<40kg): 200mg twice daily; ≥40kg: 300mg twice daily. Chew tabs max dose: 300mg twice daily. The 25mg chew tabs may be crushed for those who have difficulty chewing. See full labeling.

Isentress Contraindications

Not Applicable

Isentress Boxed Warnings

Not Applicable

Isentress Warnings/Precautions

Warnings/Precautions

Chew tabs or oral susp are not interchangeable with the film-coated tabs. Monitor liver aminotransferases, myopathy, and rhabdomyolysis. Discontinue if signs/symptoms of severe skin or hypersensitivity reactions develop. Hepatic impairment: Isentress HD not recommended. Pregnancy. Nursing mothers: not recommended.

Isentress Pharmacokinetics

See Literature

Isentress Interactions

Interactions

May be antagonized by UGT1A1 inducers (eg, rifampin; see Adult dose) and potentiated by UGT1A1 inhibitors. Concomitant aluminum and/or magnesium-containing antacids, other strong enzyme inducers (eg, carbamazepine, phenobarbital, phenytoin): not recommended. Caution with concomitant drugs known to cause myopathy or rhabdomyolysis (eg, statins). Isentress HD: concomitant calcium carbonate antacid, rifampin, tipranavir/ritonavir, etravirine: not recommended.

Isentress Adverse Reactions

Adverse Reactions

Insomnia, headache, dizziness, nausea, fatigue, creatinine kinase elevations, myopathy, rhabdomyolysis; severe skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis), hypersensitivity, immune reconstitution syndrome.

Isentress Clinical Trials

See Literature

Isentress Note

Notes

Register pregnant patients exposed to raltegravir by calling (800) 258-4263.

Isentress Patient Counseling

See Literature