WARNING

Astagraf XL (Generic Tacrolimus) is an immunosuppressant used to prevent organ rejection after a kidney transplant. However, it carries several risks and potential side effects:

• Increased Risk of Infections: Tacrolimus suppresses the immune system, making it easier to develop infections.
• Kidney and Liver Problems: It can cause kidney damage or increase liver enzymes, potentially leading to kidney or liver failure.
• High Blood Pressure: Common in patients taking Tacrolimus, requiring regular monitoring and management.
• Increased Risk of Cancer: Prolonged use may increase the risk of developing skin cancer and lymphomas.
• Blood Sugar Levels: Can cause high blood sugar or diabetes, particularly in patients with a family history of diabetes.
• Neurological Side Effects: May cause tremors, headaches, dizziness, and changes in mental state.
• Electrolyte Imbalances: It can lead to low magnesium or high potassium levels, requiring monitoring and possible supplementation.

Regular medical monitoring is necessary to manage these risks and adjust dosages as needed.

Why is this medication prescribed?

Astagraf XL (Generic Tacrolimus) is prescribed to prevent organ rejection in patients who have received a kidney transplant. It helps the body accept the new organ by suppressing the immune system, which would otherwise recognize the transplanted kidney as foreign and try to attack or reject it. Astagraf XL is typically used in combination with other immunosuppressants and is part of a broader immunosuppressive regimen tailored to the individual patient’s needs.

How should this medicine be used?

How to Use Astagraf XL:

• Dosage and Administration: Astagraf XL comes as an extended-release capsule and is taken orally. It is usually taken once a day, preferably in the morning. Should be taken at the same time every day, with or without food, but always in the same manner (either always with food or always without food) to maintain consistent blood levels. Capsules should be swallowed whole, not crushed, chewed, or opened.
• Dosage Adjustments: The dosage is individualized based on the patient’s medical condition, blood levels, kidney function, and response to the medication. Regular blood tests may be required to monitor the levels of Tacrolimus and adjust the dose accordingly.
• Missed Dose: If a dose is missed, take it as soon as remembered, unless it is close to the time of the next dose. Do not double the dose to catch up.
• Avoid Certain Substances: Avoid grapefruit and grapefruit juice, as they can interfere with the metabolism of Tacrolimus, potentially leading to increased blood levels and risk of side effects. Avoid alcohol, as it can increase the risk of kidney and liver damage.
• Stay Hydrated and Follow Doctor’s Instructions: Drink plenty of fluids to stay hydrated. Follow all additional instructions provided by the healthcare provider regarding diet, lifestyle, and other medications.

Regular monitoring and follow-up with the healthcare provider are essential to ensure the drug’s effectiveness and minimize potential side effects or complications.

Other uses for this medicine

While the primary use of Astagraf XL is to prevent organ rejection in kidney transplant patients, it may sometimes be used off-label for other purposes, such as:

• Prevention of Rejection in Other Organ Transplants: It may be used in certain cases for preventing rejection after liver, heart, or lung transplants, although this is not its primary indication.
• Treatment of Autoimmune Diseases: Tacrolimus may be considered for treating certain autoimmune conditions (e.g., lupus, myasthenia gravis) when other treatments are not effective, though this use is less common and off-label.
• Graft-versus-Host Disease (GVHD): It may be used to prevent or treat GVHD following bone marrow or stem cell transplantation.

What special precautions should I follow?

Special Precautions to Follow for Astagraf XL:

• Inform Your Doctor: Tell your doctor if you have a history of kidney or liver disease, diabetes, high blood pressure, heart problems, infections, or any other serious health conditions. Mention any allergies, especially to Tacrolimus or any of its components.
• Avoid Certain Foods and Beverages: Avoid consuming grapefruit or grapefruit juice, as they can interfere with how Tacrolimus is metabolized, leading to higher levels in the blood and increased risk of side effects. Limit or avoid alcohol, as it can increase the risk of liver damage.
• Risk of Infections: Tacrolimus suppresses the immune system, increasing the risk of infections. Practice good hygiene, avoid contact with sick individuals, and report any signs of infection (fever, sore throat, cough) to your doctor promptly.
• Monitor for Side Effects: Be aware of potential side effects, including kidney problems, high blood pressure, diabetes, neurological symptoms (like tremors, headaches), and electrolyte imbalances. Regular monitoring through blood tests and check-ups is essential.
• Sun Exposure: Tacrolimus may increase sensitivity to sunlight and the risk of skin cancer. Use sunscreen, wear protective clothing, and avoid prolonged sun exposure.
• Pregnancy and Breastfeeding: Inform your doctor if you are pregnant, planning to become pregnant, or breastfeeding. Tacrolimus can affect fetal development and may pass into breast milk.
• Drug Interactions: Inform your healthcare provider of all medications, supplements, and herbal products you are taking, as Tacrolimus can interact with many drugs, affecting its effectiveness or increasing the risk of side effects.
• Avoid Vaccinations: Do not get live vaccines while taking Tacrolimus, as it can affect your ability to develop an appropriate immune response.
• Stay Hydrated: Drink plenty of fluids to help prevent kidney problems, and avoid dehydration.

By following these precautions, you can minimize potential risks and ensure that Astagraf XL is used safely and effectively.

What special dietary instructions should I follow?

• Grapefruit and Grapefruit Juice: Avoid consuming grapefruit and grapefruit juice, as they can significantly affect how Tacrolimus is metabolized, leading to increased blood levels and risk of side effects.
• Alcohol: Limit or avoid alcohol, as it can affect liver function and increase the risk of complications.

What should I do if I forget a dose?

• Missed Dose: If you miss a dose of Astagraf XL, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and resume your regular schedule.
• Do Not Double Dose: Avoid taking a double dose to make up for a missed one, as this can increase the risk of side effects.

What side effects can this medication cause?

Astagraf XL (Generic Tacrolimus) can cause a variety of side effects. Here’s a breakdown of common, and serious side effects:

Common Side Effects:

• Tremors: Shaking or trembling, particularly in the hands.
• Headaches: Frequent or severe headaches.
• Digestive Issues: Nausea, vomiting, diarrhea, or constipation.
• Fatigue: Feeling unusually tired or weak.
• Insomnia: Difficulty falling or staying asleep.
• Skin Reactions: Rash or itching.

Serious Side Effects:

• Kidney Problems: Elevated creatinine levels or signs of kidney dysfunction, such as swelling in the legs, ankles, or feet.
• Liver Damage: Elevated liver enzymes or symptoms like jaundice (yellowing of the skin or eyes), dark urine, or abdominal pain.
• High Blood Pressure: Elevated blood pressure, which may need treatment.
• Diabetes: Increased blood sugar levels or new-onset diabetes.
• Infections: Increased susceptibility to infections due to immune suppression. Symptoms might include fever, sore throat, or persistent cough.
• Neurological Issues: Seizures, confusion, mood changes, or other mental changes.
• Electrolyte Imbalances: Abnormal levels of potassium or magnesium, which can cause muscle cramps or irregular heartbeats.
• Gastrointestinal Issues: Severe abdominal pain or persistent diarrhea.
• Cancer Risk: Increased risk of developing skin cancer or lymphomas with long-term use.
• Allergic Reactions: Severe allergic reactions, including rash, itching, swelling, or difficulty breathing.
• Acute Kidney Injury: Sudden and severe deterioration in kidney function that requires immediate medical attention.

Regular monitoring through blood tests and follow-up visits with your healthcare provider is essential to manage these risks.

What should I know about storage and disposal of this medication?

Storage and Disposal of Astagraf XL:

Storage:

• Store Astagraf XL at room temperature, away from moisture and heat. Typically, this means keeping it at temperatures between 68°F and 77°F (20°C to 25°C).
• Keep the medication in its original container with the lid tightly closed.
• Keep Astagraf XL out of reach of children and pets to prevent accidental ingestion.

Disposal:

• Dispose of any unused or expired medication properly. Do not flush it down the toilet or throw it in the trash.
• Use drug take-back programs or facilities if available in your area. Many pharmacies and local communities offer disposal programs for medications.
• For specific disposal instructions, consult your pharmacist or healthcare provider.

In case of emergency/overdose

• Symptoms of Overdose: Symptoms of an overdose may include severe nausea, vomiting, diarrhea, confusion, tremors, or signs of kidney damage such as swelling in the legs or ankles.
• Seek Immediate Medical Attention: If you suspect an overdose, contact emergency medical services or go to the nearest emergency room immediately.
• Provide Information: Be prepared to provide information about the amount of Astagraf XL taken, the time of ingestion, and any other relevant details to medical professionals.

What other information should I know?

• Regular Monitoring: Frequent blood tests and follow-up appointments with your healthcare provider are crucial to monitor the drug’s effectiveness, adjust dosages, and manage side effects.
• Medication Adherence: Take the medication exactly as prescribed, and do not alter your dosage or stop taking it without consulting your healthcare provider.
• Medication Interactions: Be aware of potential drug interactions with other medications, including over-the-counter drugs, supplements, and herbal products. Always inform your healthcare provider of all substances you are taking.
• Health Status Updates: Keep your healthcare provider updated on any new symptoms, changes in health status, or other concerns.

By following these guidelines, you can help ensure the safe and effective use of Astagraf XL. If you have any questions or need further clarification, consult your healthcare provider or pharmacist.