What are the most common side effects of CABOTEGRAVIR AND RILPIVIRINE?

Reported side effects vary by individual. The side-effects section on this page lists the events most frequently reported to FDA FAERS for CABOTEGRAVIR AND RILPIVIRINE. FAERS is voluntary reporting, so it reflects what was reported, not absolute incidence.

Is CABOTEGRAVIR AND RILPIVIRINE the same as its brand-name version?

CABOTEGRAVIR AND RILPIVIRINE is the generic name. The active ingredient is the same across any brand-name or generic versions approved by the FDA.

CABOTEGRAVIR AND RILPIVIRINE

Q: What is CABOTEGRAVIR AND RILPIVIRINE used for?

CABOTEGRAVIR AND RILPIVIRINE is a Other indicated for Clinical Studies ( 14.1 )] . CABENUVA, a 2-drug co-packaged product of cabotegravir, an HIV-1 integrase strand transfer inhibitor (INSTI).

Q: How does CABOTEGRAVIR AND RILPIVIRINE work?

CABOTEGRAVIR AND RILPIVIRINE works through the following mechanism: 12.1 Mechanism of Action CABENUVA contains 2 long-acting HIV-1 antiretroviral drugs, cabotegravir and rilpivirine [see Microbiology ( 12.4 )] ..

Other

Oral

Mechanism of Action

12.1 Mechanism of Action CABENUVA contains 2 long-acting HIV-1 antiretroviral drugs, cabotegravir and rilpivirine [see Microbiology ( 12.4 )] .

Indications

Clinical Studies ( 14.1 )] . CABENUVA

a 2-drug co-packaged product of cabotegravir

an HIV-1 integrase strand transfer inhibitor (INSTI)

and rilpivirine

an HIV-1 non‑nucleoside reverse transcriptase inhibitor (NNRTI)

Contraindications

• which may result in loss of virologic response [see Drug Interactions ( 7 )
• Clinical Pharmacology ( 12.3 )] : o Anticonvulsants: Carbamazepine
• oxcarbazepine
• phenobarbital
• phenytoin o Antimycobacterials: Rifabutin

FDA Warnings

5 WARNINGS AND PRECAUTIONS • Serious or severe hypersensitivity reactions have been reported with cabotegravir- and rilpivirine-containing regimens
1 ) • Serious post-injection reactions with rilpivirine were reported
1 Hypersensitivity Reactions Serious or severe hypersensitivity reactions have been reported with cabotegravir- and rilpivirine-containing regimens
Administration of cabotegravir and rilpivirine oral lead-in dosing was used in clinical studies to help identify patients who may be at risk of a hypersensitivity reaction [see Dosage and Administration ( 2

Known Side Effects

3 documented side effects by frequency

Injection Site Pain

>10%

Fever

0.1-1%

Fatigue

0.1-1%

Community Discussions

No community discussions found for CABOTEGRAVIR AND RILPIVIRINE yet.

Primary sources

Every figure on this page links back to its primary source. See data sources for full provenance.

DailyMed FDA label search → CABOTEGRAVIR AND RILPIVIRINE openFDA label JSON → CABOTEGRAVIR AND RILPIVIRINE FAERS adverse-event reports → CABOTEGRAVIR AND RILPIVIRINE ClinicalTrials.gov → completed Phase 2+ trials of CABOTEGRAVIR AND RILPIVIRINE

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Formulations

Dosage Forms

Tablet

Route

Oral