APREMILAST kit APREMILAST tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

APREMILAST (UNII: UP7QBP99PN) (APREMILAST - UNII:UP7QBP99PN)

Available from:

Amneal Pharmaceuticals NY LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Apremilast tablets are indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Apremilast tablets are contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation [see Adverse Reactions (6.1)]. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to apremilast during pregnancy. Information about the registry can be obtained by calling 1-877-311-8972. Risk Summary Available pharmacovigilance data with apremilast use in pregnant women have not established a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes, but these data are extremely limited. Based on findings from animal reproduction studies, apremilast may increase the risk for fetal loss. In animal embryo-fetal development studies, the administration of apremilast to pregnant cynomolgus monkeys during orga

Product summary:

Apremilast Tablets, 10 mg are supplied as pink colored, oval shaped, film-coated tablets, debossed with “C12” on one side and plain on other side. Apremilast Tablets, 20 mg are supplied as brown colored, oval shaped, film-coated tablet, debossed with "C13” on one side and plain on other side. Apremilast Tablets, 30 mg are supplied as beige colored, oval shaped, film-coated tablets, debossed with “C14" on one side and plain on other side. Tablets are supplied in the following strengths and package configurations: Package Configuration Tablet Strength NDC number Bottles of 60 30 mg NDC 60219-1410-6 Two week starter pack 13-tablet blister titration pack containing: (4) 10-mg, (4) 20-mg, and (5) 30-mg tablets with an additional (14) 30-mg tablets Storage and Handling Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

APREMILAST- APREMILAST
APREMILAST- APREMILAST TABLET, FILM COATED
AMNEAL PHARMACEUTICALS NY LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
APREMILAST TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
APREMILAST TABLETS.
APREMILAST TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2014
INDICATIONS AND USAGE
Apremilast, an inhibitor of phosphodiesterase 4 (PDE4), is indicated
for the treatment of:
Adult patients with moderate to severe plaque psoriasis who are
candidates for phototherapy or
systemic therapy. (1.2)
DOSAGE AND ADMINISTRATION
To reduce risk of gastrointestinal symptoms, titrate to recommended
dose of 30 mg twice daily
according to the following schedule. (2.1)
Day 1: 10 mg in morning
Day 2: 10 mg in morning and 10 mg in evening
Day 3: 10 mg in morning and 20 mg in evening
Day 4: 20 mg in morning and 20 mg in evening
Day 5: 20 mg in morning and 30 mg in evening
Day 6 and thereafter: 30 mg twice daily
Dosage in Severe Renal Impairment:
Recommended dose is 30 mg once daily. (2.2)
For initial dosage titration, titrate using only morning schedule
listed in Table 1 and skip afternoon
doses. (2.2)
DOSAGE FORMS AND STRENGTHS
Tablets: 10 mg, 20 mg, 30 mg. (3)
CONTRAINDICATIONS
Known hypersensitivity to apremilast or any excipients in formulation.
(4)
WARNINGS AND PRECAUTIONS
Diarrhea, Nausea, and Vomiting: Consider apremilast dose reduction or
suspension if patients develop
severe diarrhea, nausea, or vomiting. (5.1)
Depression: Advise patients, their caregivers, and families to be
alert for the emergence or worsening
of depression, suicidal thoughts or other mood changes and if such
changes occur to contact their
healthcare provider. Carefully weigh risks and benefits of treatment
with apremilast in patients with a
history of depression and/or suicidal thoughts or behavior. (5.2)
Weight Decrease: Monitor weight regularly. If unexplained or
clinically significant weight loss occurs,
evaluate weight loss and consider discontin