Isentress Hd

— THERAPEUTIC CATEGORIES —
  • Viral infections

Isentress Hd Generic Name & Formulations

General Description

Raltegravir (as potassium) 600mg; 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 Hd Indications

Indications

HIV-1 infection, in combination with other antiretrovirals.

Isentress Hd 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 Hd Contraindications

Not Applicable

Isentress Hd Boxed Warnings

Not Applicable

Isentress Hd 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 Hd Pharmacokinetics

See Literature

Isentress Hd 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 Hd 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 Hd Clinical Trials

See Literature

Isentress Hd Note

Notes

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

Isentress Hd Patient Counseling

See Literature

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