Classes
DEA Class; Rx
Common Brand Names; Selzentry
- HIV, CRAs
Description
Entry inhibitor
Used for treatment of CCR5-tropic human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents
Tropism assay of the HIV strain required prior to treatment
Indications
Indicated in combination with other antiretroviral agents for treatment of only CCR5-tropic human immunodeficiency virus type 1 (HIV-1) infection
Contraindications
Hypersensitivity
Severe renal impairment or end-stage renal disease (CrCl <30 mL/min) in patients taking potent CYP3A4 inhibitors or inducers
Adverse Effects
- Upper respiratory infections (20%)
- Arthritis and musculoskeletal S/S (15%)
- Cough (13%)
- Pyrexia (12%)
- Rash (11%)
- Fever (13%)
- Dizziness (9%)
- Appetite disorder (8%)
- Herpes infection (8%)
- Bronchitis (7%)
- Sinusitis (7%)
- Constipation (6%)
- Apocrine and eccrine gland disorder (5%)
- Paresthesia/dysesthesia (5%)
- Renal/urinary disorder (3-5%)
- Depression (4%)
- Disturbed consciousness (4%)
- Periph neuropathies (4%)
- Pruritus (4%)
- Sensory abnormalities (4%)
- Folliculitis (3%)
- Hypertension (3%)
- Lipodystrophy (3%)
- Muscle pain (3%)
- Influenza (2%)
- Pneumonia (2%)
- Condyloma acuminata
- Dermatitis/eczema
- Dyspepsia
- GI pain
- Stomatitis/ulceration
Warnings
Risks of hepatotoxicity
Risk of immune reconstitution syndrome if used in combination with other antiretroviral drugs
Autoimmune disorders (eg, Graves’ disease, polymyositis, Guillain-Barré syndrome) reported in the setting of immune reconstitution, however, the time to onset is more variable, and can occur many months after initiation of treatment
Do not use in treatment-naïve patients; more likely to experienced virologic failure and developed lamivudine resistance compared to efavirenz
Tropism testing with a highly sensitive tropism assay is required for the appropriate use
Evaluate if signs/symptoms of hepatitis, increase LFTs, or rash develop
Preexisting liver dysfunction or viral hepatitis B or C coinfection
Patient history of increased risk for cardiovascular events
History of postural hypotension or concomitant use of blood pressure lowering medication
Caution in renal and hepatic impairment; postural hypotension reported in patients with renal impairment
Monitor for developing infections
When administering to patients with pre-existing liver dysfunction or who are co-infected with hepatitis B and/or C virus, additional monitoring may be warranted
Cardiovascular adverse events triggered by postural hypotension’ additional monitoring may be warranted
Pregnancy and Lactation
Pregnancy: Limited data on pregnancy from the APR and case reports are not sufficient to inform a drug-associated risk of birth defects and miscarriage; n animal reproduction studies, no evidence of adverse developmental outcomes observed with maraviroc
Lactation: Centers for Disease Control and Prevention recommend that HIV-1-infected mothers in United States not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection
Maximum Dosage
600 mg/day PO; 1,200 mg/day PO if taking a potent or moderate CYP3A inducer; 300 mg/day PO if taking a potent CYP3A inhibitor.
600 mg/day PO; 1,200 mg/day PO if taking a potent or moderate CYP3A inducer; 300 mg/day PO if taking a potent CYP3A inhibitor.
weighing 40 kg or more: 600 mg/day PO; 300 mg/day PO if taking a potent CYP3A inhibitor; use not recommended with potent or moderate CYP3A inducers.
weighing 30 to 39 kg: 600 mg/day PO; 200 mg/day PO if taking a potent CYP3A inhibitor; use not recommended with potent or moderate CYP3A inducers.
weighing 40 kg or more: 600 mg/day PO; 300 mg/day PO if taking a potent CYP3A inhibitor; use not recommended with potent or moderate CYP3A inducers.
weighing 30 to 39 kg: 600 mg/day PO; 200 mg/day PO if taking a potent CYP3A inhibitor; use not recommended with potent or moderate CYP3A inducers.
weighing 20 to 29 kg: 400 mg/day PO; 150 mg/day PO for tablets and 160 mg/day PO for solution if taking a potent CYP3A inhibitor; use not recommended with potent or moderate CYP3A inducers.
weighing 14 to 19 kg: 400 mg/day PO; 100 mg/day PO if taking a potent CYP3A inhibitor; use not recommended with potent or moderate CYP3A inducers.
weighing 10 to 13 kg: 300 mg/day PO; 100 mg/day PO if taking a potent CYP3A inhibitor; use not recommended with potent or moderate CYP3A inducers.
weighing 6 to 9 kg: 200 mg/day PO for solution; use not recommended with potent or moderate CYP3A inducers or potent CYP3A inhibitors.
weighing 6 to 9 kg: 200 mg/day PO for solution; use not recommended with potent or moderate CYP3A inducers or potent CYP3A inhibitors.
weighing 4 to 5 kg: 80 mg/day for solution; use not recommended with potent or moderate CYP3A inducers or potent CYP3A inhibitors.
weighing 2 to 3 kg: 60 mg/day for solution; use not recommended with potent or moderate CYP3A inducers or potent CYP3A inhibitors.
weighing 4 to 5 kg: 80 mg/day for solution; use not recommended with potent or moderate CYP3A inducers or potent CYP3A inhibitors.
weighing 2 to 3 kg: 60 mg/day for solution; use not recommended with potent or moderate CYP3A inducers or potent CYP3A inhibitors.
How supplied
maraviroc
tablet
- 150mg; 300mg (Selzentry, generic)
oral solution
- 20mg/mL
