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Home > Drug Category > Immunosuppressive Agents > Astagraf XL and Equivalent

Astagraf XL Information

Astagraf XL (Tacrolimus Extended Release) is primarily used to prevent organ rejection in adult and pediatric patients (typically 5 years of age and older) who have received a kidney transplant, as well as to treat graft-versus-host disease in stem cell transplant recipients. It is primarily used for kidney transplants; tacrolimus can also be used for transplants of other organs, such as the lungs and the heart. It is often prescribed as part of a multidrug regimen that includes other immunosuppressants, such as mycophenolate mofetil, and corticosteroids. Tacrolimus may also be used to treat various autoimmune or inflammatory conditions, such as refractory ulcerative colitis, myasthenia gravis, and lupus nephritis. Tacrolimus is a calcineurin inhibitor that typically works by inhibiting calcineurin, a protein involved in the immune response, thereby suppressing immune activity and reducing the risk of organ rejection after transplantation.

When a person receives an organ, such as a kidney or heart, from a donor, their immune system naturally recognizes the new tissue as foreign or non-self, as it would a virus or bacteria. This triggers a T-cell-mediated attack that can lead to inflammation, tissue damage, and eventually the failure or rejection of the transplanted organ. Astagraf XL helps by essentially suppressing this immune response. Suppressing T-cell activity allows the body to tolerate the foreign organ, ensuring the transplanted kidney can continue its vital functions of filtering blood and maintaining fluid balance without being destroyed by the patient’s own defenses.

Astagraf XL Side Effects

The side-effect profile of this medication appears to be consistent with other tacrolimus formulations, though the peak-to-trough fluctuations may be smoother with the extended-release formulation. Common mild side effects of this medication include shaking, headache, diarrhea, mild nausea and vomiting, stomach discomfort, loss of appetite, trouble sleeping, and numbness or tingling of the hands and feet. Contact your doctor if these mild side effects persist or worsen.

Stop taking this medicine and contact your doctor immediately if you experience any serious side effects, including the following:
• Allergic reactions such as breathing difficulties, body itching, body rash, skin blistering, swelling of the face, mouth, tongue, lips, or throat;
• Anemia (low red blood cells) with symptoms like dizziness, pale skin, unusual tiredness or weakness, shortness of breath;
• Blood clotting problems;
• Electrolyte imbalances like high levels of potassium in your blood with symptoms such as muscle weakness, irregular heartbeat;
• High blood pressure;
• High blood sugar with symptoms like frequent urination, confusion, fruity smell on your breath, and increased thirst or hunger;
• Kidney problems;
• Nervous system problems such as confusion, numbness and tingling, vision changes, and tremors

Inform your doctor about any other side effects you notice that are not listed here.

Astagraf XL Precautions

Do not use this medicine if you are allergic to tacrolimus or any other ingredients in Astagraf XL. Before using this medication, ensure you inform your doctor about any medical conditions you previously or currently have, including the following:
• Cancer;
• Current infections;
• Diabetes;
• Electrolyte imbalances such as high levels of potassium;
• Heart disease;
• High blood pressure;
• Kidney disease;
• Liver disease;
• Reversible posterior leukoencephalopathy syndrome (RPLS)

Avoid the intake of alcohol while taking this medication, as it appears to trigger a dangerous dose dump of the medication into your bloodstream. Grapefruit and grapefruit juice must be avoided entirely as they inhibit intestinal enzymes and can significantly increase tacrolimus levels. Limit your skin's exposure to sunlight and wear sunscreen and protective clothing when outdoors, as this medication can make your skin more sensitive to sunlight. Tacrolimus users have an increased risk of skin cancers (specifically squamous cell carcinoma) due to long-term immunosuppression. Patients require regular blood draws to monitor "trough levels" of tacrolimus. Because the therapeutic window is so narrow, even small changes in brand or diet can push the levels from "effective" to "toxic. There is a high risk of developing mild or serious infections (bacterial, viral, fungal, and protozoal), including opportunistic infections such as cytomegalovirus, while taking this medication, as it can affect your immune system, lowering its ability to fight infections. As a result, avoid contact with anyone who has an infection that may easily spread, such as chickenpox, COVID-19, measles, or the flu.

Clinical trials observed an increased risk of death in female liver transplant patients treated with Astagraf XL. Consequently, it is generally not recommended for use in liver transplantation. Astagraf XL is known to cross the placenta, with potential risk of prematurity, low birth weight, and neonatal hyperkalemia or renal dysfunction in the fetus. This medication is not recommended for use during pregnancy unless the benefit to the mother outweighs the risk to the fetus. Women of reproductive age and men who have female partners of reproductive age should use effective birth control methods while taking this medication. Consult your doctor before using this medication while breastfeeding, as it can pass through breast milk.

Before having a vaccine, inform your healthcare provider that you are taking this medication. Medications like ketoconazole, clarithromycin, and ritonavir can cause tacrolimus levels to spike dangerously, causing adverse effects. Therefore, make sure you inform your doctor about all the medications, including herbal medications and supplements, you are taking before starting Astagraf XL to prevent drug interactions. Take Astagraf XL once daily at the same time each day. Your doctor will determine the appropriate dose of this medication for you. Swallow the capsules whole with water; never crush, chew, or break them. You must ingest each dose on an empty stomach, ideally 1 hour before or 2 hours after breakfast. Maintain your prescribed dosage schedule to stabilize the drug levels your body needs to protect the graft. Store this medication in a cool, dry place, protect it from light and moisture, and keep it out of reach of children.

Do I need a prescription to order Astagraf XL?

Yes, a prescription is required from your physician to order Astagraf XL.