What precautions should be taken when using Pralsetinib?

Pralsetinib may interfere with the efficacy of hormonal contraceptives (including birth control pills, patches, vaginal rings, implants, or injections). These should not be used as the sole contraceptive method during treatment.

What precautions should be taken when using Pralsetinib?

Inform your doctor if you are pregnant, planning to become pregnant, or planning to father a child. You must use non-hormonal contraceptive methods, such as barrier methods (devices that prevent sperm from entering the uterus, e.g., condoms or cervical caps). Consult your doctor to select an appropriate contraceptive method.

If you are a female, you will need to take a pregnancy test before initiating treatment, and use a non-hormonal contraceptive method during treatment and for 2 weeks after the last dose to prevent pregnancy.

If you are a male and your partner has the potential to become pregnant, you should use effective contraceptive measures during treatment and for 1 week after the last dose to prevent pregnancy.

If you or your partner becomes pregnant while taking Pralsetinib, contact your doctor immediately. Pralsetinib may cause fetal harm.

Inform your doctor if you are breastfeeding or planning to breastfeed. Breastfeeding is not recommended during treatment with Pralsetinib and for 1 week after the last dose.

Please note that this medication may impair fertility in both males and females. Discuss the risks of taking Pralsetinib with your doctor.

If you need to undergo any surgery (including dental procedures), inform your doctor or dentist that you are taking Pralsetinib. Your doctor may instruct you to discontinue Pralsetinib 5 days prior to surgery and will advise you on when to resume the medication.

Who should not use Pralsetinib?

Patients with hypersensitivity to any component of the medication. Individuals allergic to any ingredient of Pralsetinib must not take this drug.

Do not take Pralsetinib unless it has been prescribed by a healthcare provider. Follow the prescription instructions strictly.

Do not share Pralsetinib with others, even if they have the same medical condition as you. This may cause harm to them.

Keep Pralsetinib out of the reach of children.

Pralsetinib should be administered on an empty stomach, i.e., at least 1 hour after a meal or 2 hours before a meal.

Use of Pralsetinib in Special Populations

The decision to use a medication must be based on a careful balance of its risks and benefits. This is a joint decision to be made by you and your doctor. For Pralsetinib, the following factors should be considered:

Patients with Hypersensitivity

Inform your doctor if you have ever had any unusual or allergic reactions to this medication or any other drugs. Additionally, notify your healthcare provider of any other types of allergies, such as allergies to foods, dyes, preservatives, or animals. For over-the-counter products, carefully read the ingredient list on the label or packaging.

Pediatric Use

Sufficient studies have not been conducted to evaluate the effect of age on the efficacy of Pralsetinib for the treatment of non-small cell lung cancer (NSCLC) in the pediatric population. The safety and efficacy of Pralsetinib for this indication in children have not been established.

Adequate studies conducted to date have not identified pediatric-specific issues that would limit the efficacy of Pralsetinib for the treatment of medullary thyroid carcinoma (MTC) and thyroid cancer in children aged 12 years and older. The safety and efficacy in children under 12 years of age have not been established.

Geriatric Use

Adequate studies conducted to date have not identified geriatric-specific issues that would limit the use of Pralsetinib in elderly patients.

Lactation

Sufficient studies have not been conducted to assess the risks of Pralsetinib to infants when used by breastfeeding women. Before taking this medication during lactation, weigh the potential benefits against the potential risks.