,x
Contents
INDIVIDUAL DRUG MONOGRAPHS, 1
APPENDIXES, 1393
A. Selected New Drugs, 1393
abrocitinib oteseconazole pacritinib
daxibotulinumtoxinA-lann sodium phenylbutyrate/taurursodiol
deucravacitinib spesolimab
eflapegrastim sutimlimab-jome
elivaldogene autotemcel tapinarof
faricimab-svoa tebentafusp-tebn
futibatinib teclistamab
ganaxolone teplizumab-mzwv
mavacamten terlipressin
mirvetuximab mitapivat tirzepatide
nivolumab/relatlimab tremelimumab
olipudase alfa vutrisiran
B. Ophthalmic, Nasal, Topical, and Otic Products, 1409
C. Vaccines and Toxoids, 1422
D. Recent FDA Drug Approvals, 1427
INDEX, 1428
EVOLVE WEBSITE
• Additional Monographs
• Drug Categories
,
moderate to severe hepatic disease, do not use
HIGH ALERT
abacavir (Rx)
(ah-bak′ ah-veer)
Ziagen
Func. class.: Antiretroviral
Chem. class.: Nucleoside reverse
transcriptase inhibitor (NRTI)
Do not confuse:
abacavir/amprenavir
ACTION: Inhibitory action against
HIV-1; inhibits replication of the virus
by incorporating into cellular DNA by
viral reverse transcriptase, thereby termi-
nating the cellular DNA chain
USES: In combination with other anti-
retroviral agents for HIV-1 infection
Unlabeled uses: HIV prophylaxis fol-
lowing occupational exposure
CONTRAINDICATIONS
Black Box Warning: Hypersensitivity,
moderate/severe hepatic disease, lactic
acidosis
Precautions: Pregnancy, breastfeeding,
children <3 mo, granulocyte count
<1000/mm3 or HB <9.5 g/dL, severe renal
disease, impaired hepatic function, HLA
B5701+ (Black, White, Asian patients),
abrupt discontinuation; Guillain- Barré
syndrome, immune reconstitution
syndrome, MI, obesity, polymyositis
DOSAGE AND ROUTES
• Adult and adolescent $16 yr: PO
300 mg bid or 600 mg/day with other
antiret- rovirals
• Adolescent <16 yr and child $3
mo: PO (oral solution) 8 mg/kg bid or
16 mg/kg daily, max 300 mg bid with
other antiretrovirals; tablets 14-19 kg 150
mg bid or 300 mg daily; 20-24 kg 150
mg AM and 300 mg PM or 450 mg
daily;
$25 kg 300 mg bid or 600 mg daily
Hepatic dose
• Adult: PO (Child-Pugh A [5-6
points]) (oral solution) 200 mg bid;
Side effects: italics = common; red = life-threatening
, abacavir 1 OTHER: Fatal hypersensitivity reactions, MI,
fat redistribution, immune reconstitution
HIV prophylaxis (unlabeled)
• Adult: PO 600 mg daily as an alternative A PHARMACOKINETICS
Available forms: Tablets Rapid/extensive absorption, distributed to
300 mg; oral solution 20 extravascular space, then erythrocytes; 50%
mg/mL protein binding; extensively metab- olized
Administer: to inactive metabolites by the liver; half-life
• Give in combination with 1½ hr; excreted in urine, feces
other anti- retrovirals (unchanged); onset, peak, 1-1.5 hr,
• May give without regard to food q12hr duration unknown
around the clock
• Reduce dose in hepatic disease, use INTERACTIONS
oral sol • Do not coadminister with abacavir-
• Storage at room temperature; containing products, ribavirin, interferon
protect from light; oral solution • Increase: possible lactic acidosis—
stored at room temperature; do ribavirin
not freeze Increase: abacavir levels—alcohol
Decrease: levels of methadone, may
SIDE EFFECTS require higher dose of methadone Drug/Lab
CNS: Fever, headache, Test
malaise, insom- nia, Increase: serum glucose, triglycerides,
lethargy ALT, AST, amylase, CK
GI: Nausea, vomiting,
diarrhea, anorexia, increase NURSING CONSIDERATIONS
AST/ALT, hepatotoxicity, hepato- Assess:
megaly with steatosis • Symptoms of HIV and possible infec-
INTEG: Rash, urticaria, tions; increased temperature baseline and
hypersensitivity reactions throughout treatment
META: Lactic acidosis
Canada only Genetic warning
Contents
INDIVIDUAL DRUG MONOGRAPHS, 1
APPENDIXES, 1393
A. Selected New Drugs, 1393
abrocitinib oteseconazole pacritinib
daxibotulinumtoxinA-lann sodium phenylbutyrate/taurursodiol
deucravacitinib spesolimab
eflapegrastim sutimlimab-jome
elivaldogene autotemcel tapinarof
faricimab-svoa tebentafusp-tebn
futibatinib teclistamab
ganaxolone teplizumab-mzwv
mavacamten terlipressin
mirvetuximab mitapivat tirzepatide
nivolumab/relatlimab tremelimumab
olipudase alfa vutrisiran
B. Ophthalmic, Nasal, Topical, and Otic Products, 1409
C. Vaccines and Toxoids, 1422
D. Recent FDA Drug Approvals, 1427
INDEX, 1428
EVOLVE WEBSITE
• Additional Monographs
• Drug Categories
,
moderate to severe hepatic disease, do not use
HIGH ALERT
abacavir (Rx)
(ah-bak′ ah-veer)
Ziagen
Func. class.: Antiretroviral
Chem. class.: Nucleoside reverse
transcriptase inhibitor (NRTI)
Do not confuse:
abacavir/amprenavir
ACTION: Inhibitory action against
HIV-1; inhibits replication of the virus
by incorporating into cellular DNA by
viral reverse transcriptase, thereby termi-
nating the cellular DNA chain
USES: In combination with other anti-
retroviral agents for HIV-1 infection
Unlabeled uses: HIV prophylaxis fol-
lowing occupational exposure
CONTRAINDICATIONS
Black Box Warning: Hypersensitivity,
moderate/severe hepatic disease, lactic
acidosis
Precautions: Pregnancy, breastfeeding,
children <3 mo, granulocyte count
<1000/mm3 or HB <9.5 g/dL, severe renal
disease, impaired hepatic function, HLA
B5701+ (Black, White, Asian patients),
abrupt discontinuation; Guillain- Barré
syndrome, immune reconstitution
syndrome, MI, obesity, polymyositis
DOSAGE AND ROUTES
• Adult and adolescent $16 yr: PO
300 mg bid or 600 mg/day with other
antiret- rovirals
• Adolescent <16 yr and child $3
mo: PO (oral solution) 8 mg/kg bid or
16 mg/kg daily, max 300 mg bid with
other antiretrovirals; tablets 14-19 kg 150
mg bid or 300 mg daily; 20-24 kg 150
mg AM and 300 mg PM or 450 mg
daily;
$25 kg 300 mg bid or 600 mg daily
Hepatic dose
• Adult: PO (Child-Pugh A [5-6
points]) (oral solution) 200 mg bid;
Side effects: italics = common; red = life-threatening
, abacavir 1 OTHER: Fatal hypersensitivity reactions, MI,
fat redistribution, immune reconstitution
HIV prophylaxis (unlabeled)
• Adult: PO 600 mg daily as an alternative A PHARMACOKINETICS
Available forms: Tablets Rapid/extensive absorption, distributed to
300 mg; oral solution 20 extravascular space, then erythrocytes; 50%
mg/mL protein binding; extensively metab- olized
Administer: to inactive metabolites by the liver; half-life
• Give in combination with 1½ hr; excreted in urine, feces
other anti- retrovirals (unchanged); onset, peak, 1-1.5 hr,
• May give without regard to food q12hr duration unknown
around the clock
• Reduce dose in hepatic disease, use INTERACTIONS
oral sol • Do not coadminister with abacavir-
• Storage at room temperature; containing products, ribavirin, interferon
protect from light; oral solution • Increase: possible lactic acidosis—
stored at room temperature; do ribavirin
not freeze Increase: abacavir levels—alcohol
Decrease: levels of methadone, may
SIDE EFFECTS require higher dose of methadone Drug/Lab
CNS: Fever, headache, Test
malaise, insom- nia, Increase: serum glucose, triglycerides,
lethargy ALT, AST, amylase, CK
GI: Nausea, vomiting,
diarrhea, anorexia, increase NURSING CONSIDERATIONS
AST/ALT, hepatotoxicity, hepato- Assess:
megaly with steatosis • Symptoms of HIV and possible infec-
INTEG: Rash, urticaria, tions; increased temperature baseline and
hypersensitivity reactions throughout treatment
META: Lactic acidosis
Canada only Genetic warning
