Loading…
JAMP APREMILAST is a brand name for Apremilast, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE............................................................................. 3 CONTRAINDICATIONS.................................................................................................. 4 WARNINGS AND…
Verbatim from this product's HC label. Tap a section to expand.
JAMP
Apremilast (apremilast) is contraindicated in: • Patients with known hypersensitivity to the active substance or to any of the excipients. For a complete listing, see DOSAGE FORMS, COMPOSITION AND PACKAGING • Pregnancy • Women who are breastfeeding.
WARNINGS AND PRECAUTIONS Cardiovascular Tachyarrhythmia There have been uncommon reports of tachyarrhythmia, including atrial fibrillation, in Phase 2/3 studies. 6% for apremilast 30 mg BID patients. 3% for apremilast patients. Use with caution in patients with a history of tachyarrhythmia or conditions that can be worsened by increases in heart rate (eg, ischemic heart disease or congestive heart failure) (see ACTION AND CLINICAL PHARMACOLOGY, Cardiac Electrophysiology).
Endocrine and Metabolic Weight loss In Phase 3 studies, clinically significant weight loss was observed. Weight decreases of greater than 5% of baseline body weight were observed more frequently in women than in men. Patients treated with JAMP Apremilast should have their weight monitored regularly.
If unexplained or clinically significant weight loss occurs, weight loss should be evaluated, and discontinuation of JAMP Apremilast should be considered. Gastrointestinal Diarrhea, Nausea and Vomiting Physicians should discuss with patients and/or caregivers the potential for diarrhea, vomiting and nausea when taking JAMP Apremilast.
11%). In post-marketing reports, apremilast was associated with reports of severe diarrhea, nausea, or vomiting which in some cases, led to hospitalization (see ADVERSE REACTIONS). Most events occurred within the first few weeks of treatment.
Dosing of JAMP Apremilast should be suspended or discontinuation considered if patients develop severe adverse reactions of diarrhea, nausea or vomiting. Elderly (≥ 65 years of age) or patients taking medication or with intercurrent conditions (such as gastrointestinal illness) that lead to volume depletion or hypotension may be at a higher risk of complications, such as dehydration, hypotension and electrolyte imbalance.
Appropriate precaution should be taken to limit the risk of volume depletion when administering JAMP Apremilast in these patients. JAMP Apremilast Product Monograph Page 5 of 35 Lactose JAMP Apremilast tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take JAMP Apremilast.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Apremilast in Canada.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Immune Apremilast has not been studied in patients with severe immunological diseases, severe acute infectious diseases, or psoriasis patients treated with immunosuppressive medicinal products. Experience in patients with latent infections such as tuberculosis, viral hepatitis, herpes viral infection and herpes zoster is limited.
JAMP Apremilast should be used with caution in these patient populations. JAMP Apremilast is not recommended in combination with potent immunosupressants, including biological therapies and cyclosporine (see DRUG INTERACTIONS, DOSAGE AND ADMINISTRATION) Neurologic JAMP Apremilast was associated with an increased incidence of headache and migraine during the placebo-controlled period (see ADVERSE REACTIONS).
Physicians should discuss the potential for headache/migraine with JAMP Apremilast with their patients and/or caregivers. Psychiatric Depression In Phase 3 psoriasis studies, treatment with apremilast was associated with an increase in adverse reactions of depression during the placebo-controlled period.
48% for placebo. 5% in patients treated with apremilast 30 mg BID. Similar incidences were observed in the psoriatic arthritis and Behçet’s disease studies. Before using apremilast in patients with a history of depression and/or suicidal thoughts or behavior, prescribers should carefully weigh the risks and benefits of treatment with apremilast in such patients.
Physicians should discuss psychiatric adverse events with their patients and/or caregivers. Patients and/or caregivers should be instructed to notify the physician if these events do occur. Renal A dosage reduction of apremilast to 30 mg once daily is recommended in patients with severe renal impairment (see DOSAGE AND ADMINISTRATION and ACTION AND CLINICAL PHARMACOLOGY).
The safety and efficacy of apremilast in patients with severe renal impairment have not been evaluated. Therefore, use with caution in these patients. Assessment of renal function is recommended prior to initiation of JAMP Apremilast.
Special Populations Pregnant Women There are no adequate and well controlled studies of apremilast in pregnant women. JAMP Apremilast is contraindicated during pregnancy and should not be used in women attempting to conceive (see CONTRAINDICATIONS).
JAMP Apremilast Product Monograph Page 6 of 35 Enhanced Surveillance Program for Adverse Pregnancy Outcomes An Enhanced Surveillance Program for Adverse Pregnancy Outcomes has been established to collect information about the effect of JAMP Apremilast exposure during pregnancy.
com. Nursing Women It is not known whether apremilast, or its metabolites, are excreted in human milk. Therefore, apremilast is contraindicated in nursing women (see CONTRAINDICATIONS). Apremilast was detected in milk of lactating mice.
0-fold […]