Usual Adult Dose for HIV Infection

Option 1:
Initial dose:

• Day 1: 927 mg subcutaneously, 600 mg orally
• Day 2: 600 mg orally

• Every 6 months (+/- 2 weeks): 927 mg subcutaneously

• Day 1: 600 mg orally
• Day 2: 600 mg orally
• Day 8: 300 mg orally
• Day 15: 927 mg subcutaneously

• Every 6 months (+/- 2 weeks): 927 mg subcutaneously

Renal Dose Adjustments

No adjustment recommended
End State Renal Disease (CrCl less than 15 mL/min): Data not available

Liver Dose Adjustments

Mild to moderate hepatic impairment: No adjustment recommended
Severe hepatic impairment: Data not available

Dose Adjustments

Data not available

Precautions

CONTRAINDICATION:

• This drug should not be given with strong CYP3A inducers

Dialysis

Data not available

Other Comments

Administration advice (Subcutaneous injection):

• The subcutaneous injection of this drug is administered into the abdomen by a healthcare provider.
• Two 1.5 mL injections are required for a complete dose.
• The injection is single use only.
• In the event of a missed dose during the maintenance period, if more than 28 weeks have passed since last injection, the dosing should be re-initiated from Day 1 using either option 1 or 2 of the dosing regimen.

• Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).
• Store in original blister pack or carton.
• Injection vial should be protected from light.

• Injection preparation should be done aseptically.
• The solution in the vial should be inspected visually for particulate matter and discoloration.
• Once withdrawn, solution should be injected as soon as possible.
• Refer to manufacturer product information for additional instructions.

• Advise patients to read the FDA-approved patient labeling.
• Patients should inform their healthcare provider about any concomitant prescription/non-prescription/herbal drugs.
• Patients should be informed that this drug may remain in the body and affect certain other drugs for up to 9 months after receiving their last injection.
• Patients should contact their healthcare provider if they develop any symptoms of infection after starting this treatment as signs and symptoms of inflammation from previous infections may occur.
• Patients should be counseled about the importance of medication adherence and regular scheduled visits in order to maintain viral suppression, to reduce risk of virologic response and development of resistance.
• In the event of missed dose or discontinuation of this drug or any antiretroviral combination of this treatment, patients should contact their healthcare provider immediately.
• Patients should be informed about the occurrence of injection site reactions (ISRs) such as swelling, pain, erythema, nodule, induration, pruritus, extravasation or mass, following administration of this drug.
• ISRs such as nodules and induration may take longer to resolve, and patients should reach out to their healthcare provider if these reactions persist.
• Pregnant women may register with an antiretroviral pregnancy registry to monitor fetal outcomes of pregnant individuals exposed to this drug by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263.
• HIV-1 positive lactating women should not breastfeed as the infection can be transmitted to the baby via breast milk.