BALVERSA

Do not use Balversa in people with the following conditions:

• Hypersensitivity
• Severe liver impairment: Erdafitinib is metabolized in the liver, so individuals with severe liver impairment should avoid its use. Liver impairment can affect the metabolism and clearance of the medication, potentially leading to increased drug levels and a higher risk of adverse effects.
• Pregnancy and breastfeeding: Erdafitinib may cause harm to an unborn baby, so it is not recommended for use during pregnancy. It is also not known whether erdafitinib passes into breast milk, so breastfeeding should be avoided while taking this medication.

It is important to note that this is not an exhaustive list of contraindications. Always consult with a healthcare professional or pharmacist for a comprehensive understanding of the contraindications associated with erdafitinib, as they can provide specific guidance based on your medical history and individual circumstances.

Balversa may have the following side effects:

• Fatigue: Feeling tired or lacking energy is a common side effect of erdafitinib. It is important to rest and conserve energy when needed.
• Diarrhea: Erdafitinib may cause diarrhea, which can range from mild to severe. Staying hydrated and following a balanced diet can help manage this side effect. It is important to inform your healthcare provider if diarrhea becomes persistent or severe.
• Nausea and vomiting: Some individuals may experience nausea and vomiting while taking erdafitinib. It is important to discuss these symptoms with your healthcare provider, as they may be able to provide medications or suggestions to help manage them.
• Mouth sores: Erdafitinib can sometimes cause mouth sores or ulcers. Maintaining good oral hygiene and avoiding spicy or acidic foods can help alleviate discomfort. Notify your healthcare provider if mouth sores become severe or persistent.
• Changes in appetite: Some individuals may experience changes in appetite, such as decreased or increased appetite, while taking erdafitinib. It is important to maintain a balanced diet and inform your healthcare provider if significant changes occur.
• Hair loss: Erdafitinib may cause hair loss or thinning. This side effect is usually reversible once treatment is completed or discontinued.
• Skin reactions: Skin-related side effects, such as a rash or itching, may occur with erdafitinib. Notify your healthcare provider if you experience any skin changes or reactions.
• Changes in liver function: Erdafitinib can affect liver function, leading to changes in liver enzyme levels. Regular monitoring of liver function is usually recommended during treatment.

A serious allergy to this medication is uncommon. In any case, seek emergency medical help if you see any manifestations of a serious allergic response, including a rash, tingling or swelling particularly of the face or tongue or throat, dizziness or difficulty in breathing.

This is not a complete list of side effects. If you see other effects not recorded above, contact your physician or pharmacist.

Precautions

Take extra caution in patients with the following medical conditions:

When taking erdafitinib, there are certain precautions to keep in mind. These precautions can help ensure the safe and effective use of the medication. Here are some important precautions associated with erdafitinib:

• Eye problems: Erdafitinib can cause eye problems, including changes in vision, dry eyes, or increased sensitivity to light. Report any new or worsening eye symptoms to your healthcare provider promptly.
• Skin reactions: Some individuals taking erdafitinib may experience skin reactions, such as rash or blistering. If you notice any skin changes, inform your healthcare provider right away.
• Kidney function: Erdafitinib can affect kidney function, so regular monitoring of kidney function may be necessary during treatment. Inform your healthcare provider if you have any kidney-related issues or if you experience changes in urination or any other kidney-related symptoms.
• Pregnancy and breastfeeding: Erdafitinib may cause harm to unborn babies, so it is important to avoid pregnancy while taking this medication. Effective methods of contraception should be used during treatment and for a period of time after treatment ends. It is also not known whether erdafitinib passes into breast milk, so breastfeeding should be avoided while taking this medication.
• Driving and operating machinery: Erdafitinib can cause fatigue or changes in vision, which may affect your ability to drive or operate machinery. If you experience these side effects, it is important to avoid activities that require alertness until you know how erdafitinib affects you.

Prior to taking this medicine, tell your physician or pharmacist if you are allergic to it, or if you have some other hypersensitivities. This drug may contain inert ingredients which can cause unfavorable side effects or different issues. Talk with your pharmacist for more information.

Interactions

Balversa may interact with the following medicines:

• CYP3A4 Inducers and Inhibitors: Erdafitinib is metabolized by the CYP3A4 enzyme, so medications that either induce or inhibit this enzyme can affect the levels of erdafitinib in the body. Examples of CYP3A4 inducers include rifampin, carbamazepine, and St. John’s wort, while inhibitors include ketoconazole, clarithromycin, and grapefruit juice. Your healthcare provider can determine the appropriate dose adjustment or recommend alternative medications if needed.
• QT-Prolonging Drugs: Erdafitinib has the potential to prolong the QT interval, which can increase the risk of serious heart rhythm abnormalities. Therefore, caution should be exercised when combining erdafitinib with other drugs known to prolong the QT interval, such as certain antiarrhythmic medications, antipsychotics, and certain antibiotics. Regular monitoring of cardiac function may be necessary in these cases.
• Gastric Acid-Reducing Agents: Medications that reduce stomach acid, such as proton pump inhibitors or H2 blockers, may affect the absorption of erdafitinib. It is recommended to separate the administration of these medications by several hours to minimize any potential interaction. Your healthcare provider can provide specific instructions regarding the timing of these medications.
• Herbal Supplements and Dietary Supplements: Certain herbal supplements and dietary supplements may interact with erdafitinib. For example, St. John’s wort can induce the CYP3A4 enzyme, potentially reducing the effectiveness of erdafitinib.

Inform your physician about the drugs you take including over-the-counter medications, prescribed drugs, supplements and vitamins.

This is not a complete list of drug interactions. Approach your physician or pharmacist for more details.

The effects of certain medications can change if you consume different medications or herbal products simultaneously. This can build your risk for side effects or may cause your drugs not to work effectively. These interactions are conceivable, yet don’t generally happen. Your physician or pharmacist can prevent or oversee interactions by changing how you utilize your prescriptions or by close checking.

While utilizing this drug, don’t start, stop, or change the dose of other medicines you are using without your physician’s advice.

If you suspect an overdose, contact your doctor right away.

Available Brands:

• Balversa