vitekta (elvitegravir) Tablets
VITEKTA Rx
Generic Name and Formulations:
Elvitegravir 85mg, 150mg; tabs.
Company:
Gilead Sciences, Inc.

Select therapeutic use: Viral infections
Indications for VITEKTA:
In combination with an HIV protease inhibitor co-administered with ritonavir and with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced adults.

Limitations Of use:
Not recommended with dosage regimens or protease inhibitors other than those listed.

Adult:
Give once daily with food. 85mg once daily regimen: in combination with atazanavir 300mg once daily + ritonavir 100mg once daily; or with lopinavir 400mg twice daily + ritonavir 100mg twice daily. 150mg once daily regimen: in combination with darunavir 600mg twice daily + ritonavir 100mg twice daily; or with fosamprenavir 700mg twice daily + ritonavir 100mg twice daily; or with tipranavir 500mg twice daily + ritonavir 200mg twice daily. All regimens must be co-administered with another antiretroviral agent. Additional dosing information: see full labeling for the respective drugs.

Children:
Not established.

Contraindications:
Consult full labeling for co-administered protease inhibitor and ritonavir.

Warnings/Precautions:
Severe hepatic impairment (Child-Pugh Class C): not recommended. Elderly. Pregnancy (Cat.B). Nursing mothers: not recommended.

Interactions:
Concomitant Stribild, efavirenz, nevirapine, protease inhibitor and cobicistat: not recommended. Potentiated by atazanavir/ritonavir, lopinavir/ritonavir. May potentiate ketoconazole (max 200mg daily). Reduced efficacy with concomitant boceprevir, telaprevir: not recommended. Antagonized by phenobarbital, phenytoin, carbamazepine, oxcarbazepine, corticosteroids; consider alternatives. Concomitant other potent CYP3A inducers (eg, rifampin, rifapentine), St. John's wort: not recommended. Concomitant rifabutin: reduce rifabutin dose by at least 75% of usual (300mg/day); monitor. Concomitant didanosine: give at least 1hr before or 2hrs after elvitegravir. Separate dosing of antacids by at least 2hrs. Discontinue use of bosentan at least 36hrs prior to initiation; after at least 10 days following initiation, resume bosentan. May antagonize ethinyl estradiol: use alternative methods of non-hormonal contraception. Concomitant buprenorphine/naloxone; monitor. Concomitant methadone: may need to increase methadone dose.

Pharmacological Class:
HIV-1 integrase strand transfer inhibitor.

Adverse Reactions:
Diarrhea, nausea, headache, lab abnormalities; immune reconstitution syndrome.

Note:
Register pregnant patients by calling (800) 258-4263.

How Supplied:
Tabs—30