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FK 506 (Generic Tacrolimus)

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Tacrolimus is a potent immunosuppressive medication commonly used to prevent organ rejection in transplant patients and to treat certain autoimmune diseases like psoriasis and eczema. While it can be highly effective in managing these conditions, there are potential risks associated with its use. Some of these risks include:

  • Suppressed Immune System: Tacrolimus works by suppressing the immune system, which can increase the risk of infections. Patients taking tacrolimus are more susceptible to bacterial, viral, and fungal infections.
  • Organ Toxicity: Tacrolimus can be toxic to various organs, particularly the kidneys. Prolonged use may lead to kidney damage or dysfunction. Regular monitoring of kidney function is essential for patients on tacrolimus.
  • Hypertension: Tacrolimus can cause high blood pressure (hypertension) in some patients. Regular blood pressure monitoring and management are necessary for those taking this medication.
  • Neurological Effects: Some individuals may experience neurological side effects such as tremors, headaches, or confusion while taking tacrolimus. In rare cases, it can also lead to seizures.
  • Gastrointestinal Issues: Tacrolimus can cause gastrointestinal side effects such as nausea, vomiting, diarrhea, and abdominal discomfort.
  • Hyperglycemia: Tacrolimus may lead to elevated blood sugar levels (hyperglycemia), especially in patients with diabetes or those predisposed to developing it.
  • Skin Problems: Skin-related side effects like acne, itching, or increased susceptibility to skin infections can occur with tacrolimus use.
  • Bone Marrow Suppression: Tacrolimus may suppress bone marrow function, leading to decreased production of red blood cells, white blood cells, and platelets. This can result in anemia, increased risk of infections, and easy bruising or bleeding.

It’s important for patients taking tacrolimus to be closely monitored by their healthcare provider for these potential risks and side effects. Adjustments to the dosage or alternative treatments may be necessary based on individual health factors and response to the medication.

Why is this medication prescribed?

Tacrolimus is prescribed for several medical conditions, primarily as an immunosuppressive medication. Here are some common reasons why it may be prescribed:

  • Organ Transplantation: Tacrolimus is commonly used to prevent organ rejection in patients who have undergone kidney, liver, heart, or lung transplantation. It works by suppressing the body’s immune response, preventing it from attacking and rejecting the transplanted organ.
  • Autoimmune Diseases: Tacrolimus is also used to treat certain autoimmune diseases such as psoriasis, eczema (atopic dermatitis), and rheumatoid arthritis. In these conditions, it helps to suppress the overactive immune response that causes inflammation and tissue damage.
  • Inflammatory Bowel Disease: Tacrolimus may be prescribed to manage symptoms of inflammatory bowel diseases like Crohn’s disease and ulcerative colitis, particularly when other treatments have been ineffective.
  • Other Immune-Mediated Conditions: It can also be used off-label in the treatment of other immune-mediated conditions such as lupus nephritis, myasthenia gravis, and certain types of nephrotic syndrome.

How should this medicine be used?

As for how tacrolimus should be used, the dosage and administration instructions may vary depending on the patient’s condition, medical history, and response to treatment. However, here are some general guidelines:

  • Dosage: The dosage of tacrolimus is usually tailored to each individual patient based on factors such as body weight, organ function, and the specific condition being treated. It is typically started at a higher dose immediately after transplantation and then gradually adjusted to maintain therapeutic levels while minimizing side effects.
  • Administration: Tacrolimus is typically taken orally in the form of capsules or tablets. It should be taken consistently at the same time(s) each day, usually on an empty stomach or with food to improve absorption. It’s important to follow the healthcare provider’s instructions regarding dosing and timing.
  • Monitoring: Regular monitoring of tacrolimus levels in the blood is essential to ensure that the medication is being effectively absorbed and to prevent toxicity. Blood tests may be done frequently initially and then less frequently once stable therapeutic levels are achieved.
  • Adherence: It’s crucial to take tacrolimus exactly as prescribed by the healthcare provider. Missing doses or taking incorrect doses can increase the risk of rejection or other complications.
  • Side Effects: Patients should be aware of the potential side effects of tacrolimus and report any unusual symptoms to their healthcare provider promptly.

It’s important for patients to communicate openly with their healthcare provider about their treatment with tacrolimus, including any concerns or side effects they may experience. Adjustments to the dosage or treatment plan may be necessary based on individual response and tolerance.

Other uses for this medicine

Some of these off-label uses include:

  • Dermatologic Conditions: Tacrolimus may be prescribed for the treatment of various dermatologic conditions such as vitiligo, lichen planus, and alopecia areata.
  • Ophthalmic Conditions: Tacrolimus eye drops have been investigated for the treatment of certain ocular conditions such as dry eye syndrome, vernal keratoconjunctivitis, and uveitis.
  • Allergic Conditions: Tacrolimus ointment is sometimes used off-label for the treatment of allergic skin conditions like allergic contact dermatitis and atopic dermatitis.
  • Graft-Versus-Host Disease (GVHD): Tacrolimus may be used in the management of GVHD, a complication that can occur after bone marrow or stem cell transplantation.

What special precautions should I follow?

Regarding special precautions for tacrolimus, patients should be aware of the following:

  • Regular Monitoring: Patients taking tacrolimus should undergo regular monitoring of their blood levels to ensure therapeutic levels are maintained and to detect any signs of toxicity.
  • Infection Risk: Tacrolimus suppresses the immune system, increasing the risk of infections. Patients should take precautions to avoid exposure to infectious agents and report any signs of infection to their healthcare provider promptly.
  • Kidney Function: Tacrolimus can affect kidney function, so patients may need regular kidney function tests. It’s important to stay hydrated and follow any dietary recommendations provided by the healthcare provider.
  • Blood Pressure: Tacrolimus can cause or exacerbate hypertension (high blood pressure). Blood pressure should be monitored regularly, and lifestyle modifications or additional medications may be necessary to manage blood pressure.
  • Drug Interactions: Tacrolimus can interact with other medications, including over-the-counter drugs and herbal supplements. Patients should inform their healthcare provider of all medications and supplements they are taking to avoid potentially harmful interactions.
  • Pregnancy and Breastfeeding: Tacrolimus may harm the fetus during pregnancy and can pass into breast milk, so its use during pregnancy and breastfeeding should be carefully considered and monitored by a healthcare provider.
  • Dermatologic Precautions: Tacrolimus ointment should be used with caution on areas of the skin with active infections or open wounds, as it may increase the risk of bacterial or fungal infections.

Patients should always follow their healthcare provider’s instructions and guidance regarding the use of tacrolimus and be vigilant for any signs of adverse effects or complications.

What special dietary instructions should I follow?

Special dietary instructions for tacrolimus may include:

  • Consistent Diet: Try to maintain a consistent diet while taking tacrolimus. Changes in diet, particularly in the consumption of foods rich in potassium, can affect tacrolimus levels in the blood.
  • Avoid Grapefruit: Grapefruit and grapefruit juice can interfere with the metabolism of tacrolimus, potentially increasing its blood levels. Avoid consuming grapefruit or grapefruit products while taking tacrolimus.
  • Considerations for Kidney Function: If you have kidney dysfunction or are at risk of kidney problems, your healthcare provider may recommend specific dietary modifications, such as limiting sodium and protein intake.

What should I do if I forget a dose?

  • Take the Missed Dose: If you remember within a few hours of the missed dose, take it as soon as possible.
  • Skip the Missed Dose: If it is close to the time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to catch up.
  • Notify Your Healthcare Provider: If you frequently forget doses or have concerns about missed doses, inform your healthcare provider. They can provide guidance on managing missed doses and may adjust your treatment plan if necessary.

What side effects can this medication cause?

Tacrolimus, like many medications, can cause side effects in some individuals. These side effects can vary in severity and may affect different organ systems. Common side effects of tacrolimus include:

  • Increased susceptibility to infections: Due to its immunosuppressive effects, tacrolimus can increase the risk of developing infections, including bacterial, viral, and fungal infections.
  • Kidney toxicity: Tacrolimus can affect kidney function, leading to decreased urine output, changes in urine color or frequency, swelling, and electrolyte imbalances.
  • Hypertension (high blood pressure): Tacrolimus may cause or exacerbate hypertension, which can increase the risk of cardiovascular complications if not managed properly.
  • Neurological effects: Some individuals may experience neurological side effects such as tremors, headaches, insomnia, confusion, or seizures.
  • Gastrointestinal disturbances: Tacrolimus can cause gastrointestinal side effects such as nausea, vomiting, diarrhea, abdominal pain, and gastrointestinal bleeding in rare cases.
  • Hyperglycemia (high blood sugar): Tacrolimus may lead to elevated blood sugar levels, particularly in individuals with pre-existing diabetes or those predisposed to developing it.
  • Skin problems: Skin-related side effects such as acne, itching, rash, increased sensitivity to sunlight, and increased risk of skin infections can occur with tacrolimus use.
  • Bone marrow suppression: Tacrolimus may suppress bone marrow function, leading to decreased production of red blood cells, white blood cells, and platelets. This can result in anemia, increased susceptibility to infections, and easy bruising or bleeding.
  • Liver toxicity: In rare cases, tacrolimus may cause liver damage, resulting in symptoms such as jaundice, dark urine, abdominal pain, and fatigue.
  • Metabolic disturbances: Tacrolimus can disrupt normal metabolic processes, leading to changes in body weight, cholesterol levels, and electrolyte imbalances.

It’s important for individuals taking tacrolimus to be aware of these potential side effects and to report any unusual symptoms to their healthcare provider promptly. In some cases, adjustments to the dosage or treatment plan may be necessary to minimize side effects while maintaining therapeutic effectiveness.

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

Storage and disposal of tacrolimus:


  • Store tacrolimus at room temperature away from moisture and heat.
  • Keep the medication in its original container, tightly closed, and out of reach of children and pets.
  • Do not freeze tacrolimus.


  • Dispose of unused or expired tacrolimus properly according to local regulations or guidelines.
  • Do not flush medications down the toilet or pour them into a drain unless instructed to do so.
  • Consult with your pharmacist or healthcare provider for proper disposal methods, such as using a drug take-back program or returning them to a pharmacy.

In case of emergency/overdose

In case of emergency or overdose of tacrolimus:

  • In case of an overdose or emergency, contact your local poison control center or emergency room immediately.
  • Symptoms of overdose may include confusion, tremors, seizures, numbness or tingling in the hands or feet, rapid heartbeat, and difficulty breathing.
  • Provide as much information as possible about the amount of tacrolimus ingested and any symptoms experienced.

What other information should I know?

  • Follow your healthcare provider’s instructions carefully regarding the use of tacrolimus, including dosage, frequency, and duration of treatment.
  • Attend all scheduled appointments for monitoring of blood levels, kidney function, and other parameters.
  • Inform your healthcare provider about any other medications, supplements, or herbal remedies you are taking, as they may interact with tacrolimus.
  • Avoid grapefruit and grapefruit juice while taking tacrolimus, as they can interfere with its metabolism.
  • Wear sunscreen and protective clothing when exposed to sunlight, as tacrolimus may increase sensitivity to UV radiation.
  • Do not change the dosage or stop taking tacrolimus without consulting your healthcare provider, as sudden discontinuation can lead to rejection of transplanted organs or worsening of autoimmune conditions.

It’s essential to follow these guidelines to ensure the safe and effective use of tacrolimus and to minimize the risk of adverse effects or complications. If you have any questions or concerns about tacrolimus, don’t hesitate to discuss them with your healthcare provider or pharmacist.

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