LORAPLATZ

COMPOSITION
Lorlatinib………………100mg.

INDICATIONS
LORAPLATZ is a kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase (ALK) or ROS1 positive metastatic non-small cell lung cancer (NSCLC).

PACKAGING: 30 tablets/box.

Reg No: 03 L 0956/23
Download Loraplatz Drug Registration Certificate


Brand name: LORAPLATZ


Composition:
Each tablet contains:
Lorlatinib …………………………………100mg.


Indications:
LORAPLATZ is a kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase (ALK) or ROS1 positive metastatic non-small cell lung cancer whose disease has progressed after:
• Crizotinib and at least one other ALK inhibitor for metastatic disease.
• Alectinib as the first line inhibitor therapy for metastatic disease.
• Ceritinib as the first line ALK inhibitor therapy for metastatic disease.


Dosage:
• Recommended dosage is 100mg orally once daily or follow doctor’s advice.


Contraindications:
• Concomitant use with strong CYP3A inducers.


Warnings:
• Risk of serious hepatotoxicity with concomitant use of strong CYP3A inducers: Discontinue strong CYP3A inducers for 3 plasma half-lives of the strong CYP3A inducer prior to initiating LORAPLATZ.
• Central Nervous System (CNS) effects: CNS effects include seizures, hallucinations, and changes in cognitive function, mood (including suicidal ideation), speech, mental status and sleep. Withhold and resume Loraplatz at same or reduced dose based on severity.
• Hyperlipidemia: Initiate or increase the dose of lipid-lowering agents. Withhold and resume Lorlatinib at same or reduced dose based on severity.
• Atrioventricular block: Withhold and resume Lorlatinib at same or reduced dose based on severity
• Interstitial Lung Disease/Pneumonitis: Immediately withhold Lorlatinib in patients with suspected ILD/Pneumonitis. Permanently discontinue Lorlatinib for treatment-related ILD/pneumonitis of any severity.
• Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risks to a fetus. Advise males and females of reproductive potential to use non-hormonal contraception.


Adverse Effects:
• Most common adverse reactions (incidence ≥20%) are edema, peripheral neuropathy, cognitive effects, dyspnea, fatigue, weight gain, arthralgia, mood effects and diarrhea.


Dosage form:  White tablet


Expiry date:  24 months after date of manufacture


Packaging:  30 tablets per bottle.


Storage:
• Store in original packaging in a cool and dry place below 30ᵒC, protect from light.
• Keep out of reach of children.


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