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Tacrolimus

Advagraf Capsule

Advagraf is an immunosuppressant containing tacrolimus, primarily used against organ rejection in patients with kidney, liver, or heart transplants. Available in various strengths, it is taken twice daily on an empty stomach to maintain stable blood levels. Dosage is tailored to individual needs and adjusted based on weight and medical condition. Patients must adhere to safety guidelines including regular monitoring of blood levels, avoiding live vaccines, and protecting against sun exposure. Side effects can include tremors, high blood pressure, and kidney issues, underscoring the need for close medical supervision.

Product Overview

Advagraf is a specialized medication containing the active ingredient tacrolimus, a potent immunosuppressant used primarily to prevent the rejection of the newly transplanted organ in the patient’s body who has undergone kidney, liver, or heart transplants. This medication is FDA-approved and works by inhibiting the activity of certain immune cells that would otherwise attack the transplanted organ. By suppressing these immune responses, Advagraf significantly reduces the risk of organ rejection, helping patients maintain the health and function of their new organs.

Advagraf capsules come in several strengths, including 0.5 mg, 1 mg, 3 mg, & 5 mg, allowing for flexible dosing tailored to the patient’s needs. The capsules should be swallowed whole with water and are typically taken twice daily on an empty stomach to ensure consistent absorption. It is suitable for adult and pediatric patients, with dosage adjustments based on body weight and medical condition. The mechanism of Advagraf involves the inhibition of calcineurin, a protein important for T-cell activation, which is crucial for maintaining the body’s immune defense.

Patients taking Advagraf may experience side effects such as tremors, headaches, high blood pressure, and possible kidney issues. It’s crucial to follow prescribed precautions such as regularly monitoring blood levels and avoiding live vaccines. If a dose is missed, the next dose should be taken at the scheduled time without doubling it. In case of an overdose, immediate medical attention is necessary. Advagraf should be stored below 25 degrees Celsius in a dry place. As recommended by healthcare professionals, patients are advised to wear sunscreen & protective clothing to guard against photosensitivity reactions.

Uses of Advagraf 

  • To prevent the rejection of the newly transplanted organs in patients who have gone through kidney, liver, or heart transplantation.

How to Use Advagraf?

Dosage

Advagraf comes in prolonged-release hard capsules with the following dosage forms and strengths:

0.5 mg: Each capsule contains 0.5 mg of tacrolimus.

1 mg: Each capsule contains 1 mg of tacrolimus.

3 mg: Each capsule contains 3 mg of tacrolimus.

5 mg: Each capsule contains 5 mg of tacrolimus.

Recommended Dosage for Different Patients

Adult Kidney Transplant Patients

  • Initial dose: 0.1-0.2 mg/kg/day administered in two divided doses, usually started within 24 hours of the transplant.
  • The dose is adjusted based on clinical assessments and blood level monitoring to minimize side effects while preventing organ rejection.

Adult Liver Transplant Patients

  • Initial dose: 0.1-0.15 mg/kg/day administered in two divided doses, starting 12-18 hours after the liver transplant.
  • Dosage adjustments are based on response and blood tacrolimus levels.

Adult Heart Transplant Patients

  • Initial dose: 0.075 mg/kg/day administered in two divided doses, typically starting within 5 days of the transplant.
  • Adjustments are made based on clinical response and drug-level monitoring.

Pediatric Patients

  • The dosing in pediatric patients follows a similar framework as in adults but is often adjusted more frequently due to variations in drug metabolism and excretion in children.
  • Dose adjustments are strictly based on body weight, clinical condition, and blood drug levels.

Patients with Renal Impairment

  • Lower starting doses and careful monitoring are essential due to the increased risk of nephrotoxicity.
  • Dosage adjustments should be made based on renal function and blood tacrolimus levels.

Patients with Hepatic Impairment

  • Patients with liver dysfunction may require lower doses due to decreased drug clearance.
  • Monitoring liver function and tacrolimus blood levels is necessary to adjust the dose appropriately.

[Note: Remember these recommendations may vary depending on person to person. Discuss it with your doctor, and they’ll customize your dosage accordingly.]

How to Take It?

  • Take Advagraf exactly as your doctor prescribes, typically twice daily at 12-hour intervals. It’s important to maintain a consistent schedule to keep blood levels stable.
  • Advagraf capsules should be swallowed withtout breaking it into half with a glass of water and should not be chewed or crushed.
  • Taking Advagraf on an empty stomach in the morning, probably or at least an hour before or 2 to 3 hours after you had a meal, is recommended to enhance absorption.
  • Regular monitoring by your healthcare provider is required to adjust the dose as per your response to treatment and any side effects.
  • Blood tests are frequently necessary to check the tacrolimus levels in your body to ensure they remain within a therapeutic range.
  • Try to take Advagraf at the same time every day to maintain an even level of medication in your blood.

[Note: Your doctor will decide the right amount for you based on your condition, following guidelines and studies on the drug. They’ll adjust it as needed over time.]

How Does Advagraf Work?

Advagraf, containing the active ingredient tacrolimus, is an immunosuppressant medication used primarily to prevent organ rejection in patients who have undergone a kidney, liver, or heart transplant.It works by blocking the action of calcineurin, a crucial protein responsible for activating T-cells, which are integral to the body’s immune system response. By suppressing these immune cells, Advagraf reduces the body’s natural defense mechanism against what it perceives as foreign tissues, such as a transplanted organ. This action helps to prevent the immune system from attacking the newly transplanted organ, thus reducing the risk of rejection.

Important Safety Information

Side Effects

Common Side Effects

  • Tremor (shaking)
  • Headache
  • Nausea (feeling sick)
  • Diarrhea
  • Kidney problems
  • Hyperglycemia (raised blood glucose levels)
  • Diabetes
  • Hyperkalemia (raised blood potassium levels)
  • Hypertension (high blood pressure)
  • Insomnia (difficulty sleeping)

Serious Side Effects

  • Pancreatitis: This serious condition can potentially be fatal. If you have a history of pancreatitis, it’s important to use Advagraf cautiously.
  • Antibodies to Advagraf: Some individuals may develop antibodies against Advagraf. Elevated antibody levels can interfere with glycemic control and increase the risks of allergic reactions and reactions at the injection site.
  • Hypoglycemia (Low Blood Sugar): Advagraf, particularly when used in compliance with other medications, can lead to low blood sugar. Symptoms to watch for include shakiness, sweating, rapid heartbeat, confusion, and dizziness.
  • Allergic Reactions: Advagraf may cause severe allergic reactions, such as anaphylaxis, hives, itching, and severe rash.

[Note: Remember, this list may not cover all possible side effects. Always consult with your healthcare giver for medical advice about side effects.]

Warnings

  • Allergic Reactions: Be aware of possible severe allergic reactions. Symptoms can include hives, swelling, and difficulty breathing.
  • Infection Risk: Advagraf suppresses the immune system, increasing the risk of infections. Monitor for signs of infection, like fever or sore throat.
  • Organ Rejection: Although used to prevent organ rejection, monitor for symptoms indicating that the body might reject the transplanted organ.
  • Kidney Function: Advagraf can affect kidney function. Thus, routine monitoring of kidney function through blood tests is crucial.
  • Neurotoxicity: Be cautious of neurotoxic effects, including tremors, changes in mental status, and other neurological issues.
  • Hypertension: Advagraf may increase blood pressure; regular monitoring is necessary, and medication adjustments may be required to manage blood pressure levels.
  • Blood Sugar Levels: Monitor blood sugar levels on regular basis as Advagraf can cause changes in glucose metabolism, leading to new-onset diabetes after transplant.

Precautions

  • Inform Your Doctor: Before starting Advagraf, disclose any pre-existing liver problems or a history of diseases that may have affected your liver.
  • Monitor Symptoms: Report any strong abdominal pain, which may be accompanied by chills, fever, nausea, or vomiting.
  • Address Persistent Diarrhea: If you experience diarrhea for more than a day, consult your doctor.
  • Discuss Upcoming Vaccinations: Inform your healthcare provider about any upcoming vaccinations, as certain vaccines may not be compatible with immunosuppressant medications.
  • Herbal Interactions: Tell your doctor if you are taking any herbal preparations, especially St. John’s wort (Hypericum perforatum), as it can interact with Advagraf.
  • Routine Testing: During the initial days of treatment, you may need to undergo various routine tests (such as heart function, blood, and urine tests) to determine the most effective dose for your condition.
  • Sun Exposure: Minimize your time spent in the sun, wear protective clothing, and apply appropriate sunscreen to reduce the risk of skin reactions.

Contraindications 

Do not use Advagraf Capsules if you are allergic to tacrolimus or any of its ingredients or have allergies to certain macrolide antibiotics such as erythromycin, clarithromycin, or josamycin.

Missed Dose

Avoid taking a double dose of Advagraf to compensate for a missed dose. If you forget to take Advagraf Capsules, wait until the next dose and proceed with your regular dosing schedule.

[Note: If you have missed a medication dose and are unsure when to take the next one, immediately consult your doctor or pharmacist.]

Overdose 

An overdose of Advagraf Capsule may cause symptoms such as tremors, headaches, nausea, vomiting, skin reactions, and changes in specific enzyme levels (like creatinine or blood urea nitrogen). If you suspect an overdose of this medication, it’s crucial to see your doctor immediately or go to the nearest hospital emergency department.

[Note: If you consumed more than recommended dose, get medical help right away or call the Poison Help line at 1-800-222-1222.]

Storage

  • Store Advagraf capsules at temperatures below 25 degrees Celsius.
  • Keep the medication in a dry place.
  • Avoid storing Advagraf capsules in the bathroom.
  • Protect the capsules from direct heat, light, and humidity to maintain their efficacy.
  • Ensure the medicine packaging is tightly closed to prevent moisture ingress.
  • Store Advagraf away from children’s reach and pets.
  • Dispose of expired or unused medication properly as per the local regulations.

[Note: Discuss with your healthcare professional about the proper disposal of any unused medicine and any questions you may have regarding its storage.]

Advagraf Interactions

  • NSAIDs (Non-Steroidal Anti-Inflammatory Drugs): These can increase the risk of kidney damage when used with tacrolimus.
  • Antifungal medications (such as ketoconazole, voriconazolefluconazole, itraconazole): These can increase tacrolimus levels in the blood, potentially leading to toxicity.
  • Antibiotics (such as erythromycin, clarithromycin, rifampin): These can also alter the levels of tacrolimus in the blood, requiring close monitoring.
  • Anticonvulsants (such as phenytoin, phenobarbital, carbamazepine): These can decrease the blood levels of tacrolimus, reducing its effectiveness.
  • Calcium channel blockers: These can increase tacrolimus levels in the blood and may require dosage adjustments.
  • Grapefruit and grapefruit juice: These can increase the blood levels of tacrolimus, potentially leading to toxicity. It is generally recommended to avoid grapefruit products while taking Advagraf.
  • Protease inhibitors (used in HIV treatment): These can also increase the blood levels of tacrolimus.
  • St. John’s Wort: This herbal supplement can significantly decrease tacrolimus levels, reducing its effectiveness.
  • Immunosuppressants (such as sirolimus, cyclosporine): Using multiple immunosuppressants can increase the risk of infection and other side effects.
  • Live vaccines: While on tacrolimus, the response to vaccines may be diminished, and the risk of infection from live vaccines is increased.

[Note: This is not a complete list, and there could be other drugs that interact with Advagraf Capsules. Make sure to tell your doctor about any prescription, over-the-counter medicines, or herbal products you’re taking.]

Advagraf Alternatives

  • Prograf (tacrolimus)
  • Envarsus XR (tacrolimus extended-release)
  • Astagraf XL (tacrolimus extended-release)
  • Tacni (tacrolimus)
  • Tacrograf (tacrolimus)
  • Pangraf (tacrolimus)

[Note: Your doctor will choose what’s best for you. Don’t use any of these alternative medications without consulting your healthcare provider. Taking them by yourself may cause serious side effects.] 

Frequently Asked Questions

What are the advantages of using Advagraf?

Advagraf suppresses your immune response, normally responsible for fighting infections, thereby decreasing the likelihood of your body rejecting a transplanted organ. It is often used alongside other medications to significantly increase the success rate of transplant surgeries.

Is Advagraf Capsule an antibiotic?

No, Advagraf is not an antibiotic; it is an immunosuppressant that belongs to a class of medications known as calcineurin inhibitors. It is majorly used to prevent organ rejection after kidney, heart, or liver transplants by suppressing the immune system to help maintain the organ’s health.

Who should avoid taking Advagraf Capsule?

Advagraf should not be taken by patients who are allergic to it, those with a compromised immune system, high blood pressure, or kidney failure. It is also not recommended for pregnant or breastfeeding women or for individuals planning to receive any vaccines, such as the MMR vaccine.

Does Advagraf have the potential for abuse?

No, Advagraf Capsule does not have the potential for abuse and is, therefore, not classified as a controlled substance. Controlled substances are regulated in it due to their potential for abuse and require authorization from medical authorities for use.

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