Nintedanib Capsules

EACH  LUCININTED CAPSULES CONTAINS:

Nintedanib Capsules…………………….100mg

Nintedanib Capsules…………………….150mg

INDICATIONS

LuciNinted is indicated for the treatment of idiopathic pulmonary fibrosis (IPF). LuciNinted is also indicated for the treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. Additionally, LuciNinted is indicated to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD).

DOSAGE

Recommended Dosage

The recommended dosage of LuciNinted is 150 mg administered orally twice daily approximately 12 hours apart.

Dosage Modifications for Adverse Reactions

Management of Adverse Reactions:

• Dosage reduction to 100 mg twice daily or treatment interruption may be required for the management of adverse reactions
• If a dose of LuciNinted is missed, the next dose should be taken at the next scheduled time; advise patients not to make up for a missed dose
• Discontinue LuciNinted in patients unable to tolerate 100 mg twice daily

Specific Dosage Modifications:

• For elevated liver enzymes (ALT or AST) with liver enzyme elevations >3 times the upper limit of normal (ULN): Interrupt treatment or reduce to 100 mg twice daily
• For elevated liver enzymes >5 times ULN: Discontinue LuciNinted
• Gastrointestinal reactions: Symptomatic treatment with adequate hydration is recommended; may require treatment interruption and dosage reduction or discontinuation
• For diarrhea, nausea, or vomiting not controlled with adequate supportive care: dose reduction to 100 mg twice daily or treatment interruption may be required

Administration Instructions

• LuciNinted should be taken with food
• Swallow capsules whole with liquid
• Do not chew or crush capsules

STORAGE

Store at 20℃ to 25℃ (68℉ to 77℉), excursions permitted between 15℃ and 30℃ (59℉ and 86℉) [see USP Controlled Room Temperature]. Protect from moisture.

MANUFACTURED AND MARKETED BY

LUCIUS PHARMACEUTICALS(LAO) CO., LTD

Address: Thongmang village, Xaythany district, Vientiane Capital, Laos