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JAMP NINTEDANIB is a brand name for Nintedanib, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: JAMP Nintedanib (nintedanib) capsules are indicated for: • The treatment of Idiopathic Pulmonary Fibrosis (IPF) • To slow the rate of decline in pulmonary function in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD) • The treatment of other chronic fibrosing interstitial lung diseases…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • Treatment should be initiated by physicians experienced in the diagnosis and treatment of conditions for which JAMP Nintedanib is indicated. , at each patient visit) or as clinically indicated. Conduct liver function tests promptly in patients who reports symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice.
1 Pregnant Women). 2 Recommended Dose and Dosage Adjustment • The recommended dose of JAMP Nintedanib is 150 mg twice daily administered approximately 12 hours apart. • Dose adjustments due to adverse reactions o In addition to symptomatic treatment if applicable, the management of adverse reactions of nintedanib could include dose reduction (to 100 mg twice daily) and temporary interruption of nintedanib treatment until the specific adverse reaction has resolved to levels that allow continuation of therapy.
JAMP Nintedanib treatment may be resumed at the full recommended dose (150 mg twice daily) or a reduced dose (100 mg twice daily). If a patient does not tolerate 100 mg twice daily, treatment with nintedanib should be discontinued (see 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS).
o Cases of drug-induced liver injury (DILI), have been reported in patients treated with nintedanib. In the majority of cases, the DILI was reversible when the dose was reduced or treatment was stopped. ▪ Treatment interruption or dose reduction to 100 mg twice daily is recommended for patients whose transaminase (AST or ALT) are measured greater than 3 times to less than 5 times the upper limit of normal (ULN) without signs of liver damage.
These patients should be monitored closely. Alternative causes of the liver enzyme elevations should be investigated. Once transaminases have returned to baseline values, treatment with nintedanib may be reintroduced at a reduced dose (100 mg twice daily) which subsequently may be increased to the full recommended dose (150 mg twice daily) (see 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS).
▪ Treatment with JAMP Nintedanib should be permanently discontinued 1) if transaminase (AST or ALT) elevations are greater than 5 times ULN, or 2) if transaminase (AST or ALT) elevations are greater than 3 times ULN with clinical signs or symptoms of liver injury which may include fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice (see 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS).
). o Cases of drug-induced liver injury (DILI), have been reported in patients treated with nintedanib. In the majority of cases, the DILI was reversible when the dose was reduced or treatment was stopped. ▪ Treatment interruption or dose reduction to 100 mg twice daily is recommended for patients whose transaminase (AST or ALT) are measured greater than 3 times to less than 5 times the upper limit of normal (ULN) without signs of liver damage.
These patients should be monitored closely. Alternative causes of the liver enzyme elevations should be investigated. Once transaminases have returned to baseline values, treatment with nintedanib may be reintroduced at a reduced dose (100 mg twice daily) which subsequently may be increased to the full recommended dose (150 mg twice daily) (see 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS).
▪ Treatment with JAMP Nintedanib should be permanently discontinued 1) if transaminase (AST or ALT) elevations are greater than 5 times ULN, or 2) if transaminase (AST or ALT) elevations are greater than 3 times ULN with clinical signs or symptoms of liver injury which may include fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice (see 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS).
• Hepatic impairment o Mild hepatic impairment: In patients with mild hepatic impairment (Child Pugh A), the recommended dose of nintedanib is 100 mg twice daily approximately 12 hours apart. Treatment interruption or discontinuation for management of adverse reactions should be considered.
o Moderate and severe hepatic impairment: Treatment of patients with moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment with JAMP Nintedanib is not recommended. The safety and efficacy of nintedanib have not been investigated in patients with hepatic impairment classified as Child Pugh B and C.
• JAMP Nintedanib is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, or any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
1 Pregnant Women).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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• Hepatic impairment o Mild hepatic impairment: In patients with mild hepatic impairment (Child Pugh A), the recommended dose of nintedanib is 100 mg twice daily approximately 12 hours apart. Treatment interruption or discontinuation for management of adverse reactions should be considered.
o Moderate and severe hepatic impairment: Treatment of patients with moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment with JAMP Nintedanib is not recommended. The safety and efficacy of nintedanib have not been investigated in patients with hepatic impairment classified as Child Pugh B and C.
3 Pharmacokinetics). • Renal impairment o Adjustment of the recommended dose (150 mg twice daily) in patients with mild to moderate renal impairment is not required. The safety, efficacy, and pharmacokinetics of nintedanib have not been studied in patients with severe renal impairment (<30 mL / min CrCL).
• Geriatrics (>65 years of age) o No dose adjustment is required on the basis of a patient’s age. 4 Administration JAMP Nintedanib capsules should be taken with food, swallowed whole with water, and should not be chewed. The capsule should not be opened or crushed.
If contact with the content of the capsule occurs, hands should be washed immediately and thoroughly. 5 Missed Dose If a dose of JAMP Nintedanib is missed, administration should resume at the next scheduled time at the recommended dose.
If a dose is missed the patient should not be given an additional dose. The recommended maximum daily dose of 300 mg should not be exceeded.
3 Pharmacokinetics). • Renal impairment o Adjustment of the recommended dose (150 mg twice daily) in patients with mild to moderate renal impairment is not required. The safety, efficacy, and pharmacokinetics of nintedanib have not been studied in patients with severe renal impairment (<30 mL / min CrCL).
• Geriatrics (>65 years of age) o No dose adjustment is required on the basis of a patient’s age. 4 Administration JAMP Nintedanib capsules should be taken with food, swallowed whole with water, and should not be chewed. The capsule should not be opened or crushed.
If contact with the content of the capsule occurs, hands should be washed immediately and thoroughly. 5 Missed Dose If a dose of JAMP Nintedanib is missed, administration should resume at the next scheduled time at the recommended dose.
If a dose is missed the patient should not be given an additional dose. The recommended maximum daily dose of 300 mg should not be exceeded. 5 OVERDOSAGE There is no specific antidote or treatment for JAMP Nintedanib overdose. The highest single dose of nintedanib administered in phase 1 studies was 450 mg once daily.
In addition, 2 patients had an overdose of maximum 600 mg bid up to eight days. , increased liver enzymes and gastrointestinal symptoms. Both patients recovered from these adverse reactions. In the clinical trials in patients with IPF, one patient was inadvertently exposed to a dose of 600 mg daily for a total of 21 days.
A non-serious adverse event (nasopharyngitis) occurred and resolved during the period of incorrect dosing, with no onset of other reported events. In case of overdose, treatment should be interrupted, and general supportive measures initiated as appropriate.
For the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada's toll-free number, 1-844 POISON-X (1-844-764-7669). 60 mg nintedanib esylate, respectively Ammonium hydroxide, carmine, gelatin, glycerol, hard fat, iron oxide red, iron oxide yellow, medium chain triglycerides, propylene glycol, polyglyceryl-3 dioleate, shellac, simethicone, and titanium dioxide.
1 Physical Characteristics Table 2 Dosage Form Appearance and Packaging Dosage Form / Strength Appearance Packaging Soft capsules 100 mg Peach, opaque, oblong, soft capsule with red ink imprint “NT 100”. Capsule contains yellow viscous suspension.
Bottle of 60 capsules and 6 unit dose blister cards x 10 capsules per card. Soft capsules 150 mg Brown, opaque, oblong, soft capsule with red ink imprint “NT 150”. Capsule contains yellow viscous suspension. Bottle of 60 capsules and 6 unit dose blister cards x 10 capsules per card.
7 WARNINGS AND PRECAUTIONS General Treatment should be initiated and supervised by physicians experienced in the diagnosis and treatment of conditions for which JAMP Nintedanib is indicated. JAMP Nintedanib should be taken with food to reduce the incidence of gastrointestinal effects.
Physicians should monitor patients as frequently as clinically indicated for adverse reactions and according to the instructions of 4 DOSAGE AND ADMINISTRATION and