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Lorbrexen 100mg (Lorlatinib)

Product Name : Lorbrexen 100 mg
Generic Name : Lorlatinib
Formulation : Tablet
Available Pack Size : Box of 1 bottle x 30 tablets
Available Strengths : 100 mg
Registrations : Bangladesh
Category:

Product Description

Lorbrexen is a drug indicated for use in the treatment of cancer. Lorbrexen is researched and developed by the leading pharmaceutical company Everest - Bangladesh. Below is detailed information about the drug.

Ingredients of Lorbrexen

  • Lorlatinib.....................100mg

Dosage forms

  • Tablets.

Uses - Indications of Lorbrexen

  • ALK belongs to a family of enzymes called receptor tyrosine kinases, which are involved in the growth of cells and the growth of new blood vessels that supply them.
  • In patients with 'ALK positive' NSCLC, an abnormal form of ALK is produced which causes cancer cells to divide and grow in an uncontrolled manner.
  • The active ingredient in Lorvrexen, lorlatinib, is a tyrosine kinase inhibitor. It works by blocking the activity of ALK, thereby reducing the growth and spread of cancer cells.

Contraindications of Lorbrexen

  • Heart problems, such as "AV block" (unless you have a pacemaker);
  • Lung disease, difficulty breathing;
  • Liver failure;
  • Depression;
  • Epileptic;
  • High cholesterol or triglycerides

Dosage – How to use Lorbrexen

  • How to use: The drug is taken orally.
  • Dosage:
    • The recommended dose of lorlatinib is 100 mg PO daily, which can be taken before and after meals until disease progression or unacceptable toxicity.

Notes and precautions when using Lorbrexen

  • Significant risk of hepatotoxicity with concurrent use of strong CYP3A inducers: Discontinue the strong CYP3A inducer within 3 plasma half-lives of the strong CYP3A inducer before initiating Lorbrexen.
  • Central Nervous System (CNS) Effects: CNS effects include seizures, psychotic effects, and changes in cognitive function, mood, speech, mental status, and sleep .
  • Hyperlipidemia: Initiate or increase dose of lipid-lowering medication.
  • Atrioventricular block:
  • Interstitial Lung Disease/Pneumonia:
  • Hypertension: Monitor blood pressure after 2 weeks and then at least monthly during treatment.
  • Hyperglycemia: Assess fasting blood glucose before starting Lorbrexen and regularly during treatment. If not adequately controlled with optimal medical management.
  • Embryotoxicity: May cause harm to the fetus. Advise women of fertility about the potential risk to the fetus. Advise men and women of reproductive potential to use effective non-hormonal methods of contraception.

Use medicine for pregnant and lactating women

  • Lorlatinib may harm an unborn baby or cause birth defects.
  • If you are female, please do not use Lorlatinib if you are pregnant. Before starting this treatment, you may need to have a negative pregnancy test. Use effective birth control methods to prevent pregnancy while you are using this medication, and for at least 6 months after your last dose.

For use by drivers and machine operators

  • The drug can affect cognition, use caution when driving and operating machinery.

Side effects of Lorbrexen

  • The most common adverse reactions (incidence ≥20%) and Grade 3–4 laboratory abnormalities were edema, peripheral neuropathy, weight gain, cognitive effects, fatigue, difficulty breathing, joint pain, diarrhea, mood effects, hypercholesterolemia, hypertriglyceridemia and cough.

Drug interactions

  • Strong CYP3A inducers: Contraindicated.
  • Moderate CYP3A inducers: Avoid concomitant use. If coadministration cannot be avoided, increase the Lorbrexen dose.
  • Strong CYP3A inhibitors: Avoid concurrent use; Reduce Lorbrexen dose if concurrent use cannot be avoided.
  • Fluconazole: Avoid concurrent use; Reduce Lorbrexen dose if concurrent use cannot be avoided.
  • Certain CYP3A Substrates: Avoid concomitant use with CYP3A substrates where minimal concentration changes could result in serious treatment failure.
  • Certain P-gp substrates: Avoid concurrent use with P-gp substrates where minimal concentration changes could result in serious treatment failure.

Forgot dose and treatment

  • Take Lorlatinib at the same time each day. If a dose is missed, the missed dose is discarded unless the next dose is due within 4 hours. Do not take 2 doses at the same time to make up for a missed dose.

Overdose and treatment

  • If you vomit immediately after taking Lorlatinib, do not take another dose. Wait until the next scheduled dose time to take the medicine again.

Packing

  • Box of 1 bottle x 30 tablets

Preserve

  • Store the medicine in a dry place, away from strong light.

Expiry

  • 36 months from date of manufacture.

Manufactured by Lorbrexen

  • Everest Pharmaceuticals Ltd.