CABOTEGRAVIR

Other

Brand names: Apretude

Oral

12.1 Mechanism of Action Cabotegravir is an HIV-1 antiretroviral drug [see Microbiology ( 12.4 )] in a long-acting formulation.

2.4 )

Contraindications ( 4 )

Contraindications

• 4 CONTRAINDICATIONS APRETUDE is contraindicated in individuals: • with unknown or positive HIV-1 status [see Warnings and Precautions ( 5.1
• which may result in reduced effectiveness [see Drug Interactions ( 7.2
• 7.3 )
• Clinical Pharmacology ( 12.3 )] : o Anticonvulsants: Carbamazepine
• oxcarbazepine

5 WARNINGS AND PRECAUTIONS • Comprehensive management to reduce the risk of HIV-1 acquisition
1 ) • Potential risk of developing resistance to APRETUDE if an individual acquires HIV-1 either before or while taking APRETUDE or following discontinuation of APRETUDE
Reassess risk of HIV-1 acquisition and test before each injection to confirm HIV-1 negative status
3 ) • Serious or severe hypersensitivity reactions have been reported with cabotegravir and include Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN)

3 documented side effects by frequency

Injection Site Pain

>10%

Fever

0.1-1%

Fatigue

0.1-1%

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Dosage Forms

Tablet

Route

Oral