Prograf capsule is used for the prevention of the body rejecting liver, heart or kidney transplants after surgery. Prograf capsule is an immunosuppressants which works by weakening the body's immune system thus allowing the body to accept the transplanted organ.





Astellas Pharma


0.5mg, 1mg, 5mg

Ireland, India, Turkey

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What is Prograf?

Prograf, which is also referred to as Tacrolimus in its form, is a potent medication used after a transplant to help lower the chances of the body rejecting the transplanted organ.

Brief overview of its medical relevance

Advancements in immunosuppression have played a role in the progress of transplant medicine, and Prograf has been at the forefront of these advancements. It has become a tool for transplant recipients as it effectively reduces organ rejection and promotes the acceptance of grafts. This remarkable medication does not improve survival rates. It also enhances the overall quality of life for those who have undergone transplantation.

Uses of Prograf

Indications approved by regulatory authorities

Prograf (tacrolimus) is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney, heart, or lung transplants, in combination with other immunosuppressants 123.

Here are some references for further reading:

Benefits in transplant medicine

The main advantage of Prograf is its ability to control the body's response, which helps prevent the rejection of newly transplanted organs. This feature has made it a crucial component in transplant medicine offering patients an opportunity, for a longer and healthier life.

Other medical conditions treated by Prograf

Prograf is not used for transplant situations, but it is also utilized in managing specific autoimmune disorders. By harnessing its properties Prograf helps in controlling symptoms and preventing the progression of these diseases.

How Prograf Works

Mechanism of action

Tacrolimus, found in Prograf, works by blocking the action of calcineurin, a protein that plays a role, in producing interleukin 2. This inhibition helps to reduce the activation and growth of T cells, consequently weakening the response.

Role in immunosuppression

Prograf plays a role in preventing the rejection of grafts and reducing autoimmune responses in different disorders by explicitly targeting and controlling the immune response mediated by T cells.

Off-Label Use

Definition and considerations

Off-label use is when a medication is prescribed for a purpose, age group, dosage, or form that hasn't been officially approved by regulatory authorities. Although there may be clinical reasons behind it, careful evaluation and cautious implementation are necessary.

Common off-label indications

Prograf (tacrolimus) is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney, heart, or lung transplants, in combination with other immunosuppressants 12 .

While there is no evidence to support the use of Prograf in the treatment of dermatological conditions like eczema, some studies suggest that it may be effective in the management of certain rheumatological conditions such as psoriasis and rheumatoid arthritis .

Here are some references for further reading:

  • 1: FDA approves new use of transplant drug based on real-world evidence
  • 2: Prograf (tacrolimus) FDA Approval History -
  • : Prograf: Uses, Dosage & Side Effects -

Clinical studies supporting off-label usage

Several clinical investigations have highlighted the efficacy of Prograf in diverse non-transplant scenarios, albeit with varying degrees of empirical support. Numerous trials and case studies corroborate its effectiveness in dermatological and rheumatological disorders.

Dosage and Administration

The correct amount of Prograf varies for each person as it depends on factors such as the type of organ transplant, other medications being taken, characteristics, and any signs of graft rejection. Monitoring and adjusting the dosage to achieve the desired treatment effectiveness while minimizing any side effects is essential.

Dosage adjustments based on specific conditions

Patients with liver problems or taking CYP3A4 inhibitors at the time may need to adjust their dose to avoid any potentially harmful effects.

Modes of administration

Prograf comes in two forms: intravenous. After a transplant, most people prefer to use the version for treatment.

Duration of treatment

The duration of Prograf treatment depends on factors such as the patient's condition, the type of organ transplant they have undergone, and the likelihood of rejection. In some instances, it is a treatment that extends over a prolonged period.


Active ingredient: Tacrolimus

The pharmacological effects of Prograf are caused by a substance called Tacrolimus, which is a type of macrolide produced by the bacterium Streptomyces tsukubaensis.

Inactive ingredients and their functions

The formulation of Prograf consists of ingredients that help maintain its stability, improve how the body absorbs it, and shape its characteristics as a medication. These additional components may include substances like fillers, binders, and coating agents, which are carefully chosen based on the form and brand of the drug.

Available dosage forms and strengths

Prograf is available in strengths, in the form of capsules, and as a solution for injection for intravenous use.

Side Effects

Introduction to side effects

Similar, to medications, Prograf does have some side effects. Although its effectiveness in preventing graft rejection is undeniable, it is essential to be aware of reactions.

Common side effects experienced by patients

  • Nephrotoxicity
  • Hyperglycemia
  • Hypertension
  • Tremor

Serious side effects and their manifestations

In some cases, Prograf may cause side effects such as enlargement of the heart muscles, toxicity to the nervous system, and prolongation of QT interval. It is essential to monitor and promptly seek attention to reduce the risk associated with these adverse outcomes.


Medications that may interact with Prograf

Medications such as antifungals (like ketoconazole), macrolide antibiotics (such as erythromycin), and calcium channel blockers can potentially increase the levels of Prograf in the body. Therefore, it is essential to administer them in coordination with each other.

Food and drink considerations

Drinking grapefruit juice while undergoing therapy can significantly increase the levels of Prograf medication due to its interaction with the CYP3A4 enzyme. It is advisable to avoid consuming grapefruit juice during your treatment.

Other environmental interaction concerns

To reduce the risk of skin cancers, limiting exposure to sunlight and UV rays is advisable while undergoing Prograf therapy.


Situations in which Prograf should be used with caution

It is essential to exercise caution when considering Prograf therapy for patients who have pre-kidney problems, electrolyte imbalances, or a history of cancer.

Potential risks to certain patient populations

Elderly individuals or those who have infections may face a chance of experiencing adverse reactions and complications. It is crucial to prioritize customized treatment plans, for these groups of people.


Medical conditions that prohibit the use of Prograf

People sensitive to Tacrolimus or any of the ingredients in Prograf formulations should avoid using it. Additionally, individuals with infections or cancers that are not under control may not be suitable for this medication.

Medications incompatible with Prograf

It is not recommended to take cyclosporine along with medications due to the risk of increased harm to the kidneys.

Careful Administration

Importance of adherence

Following the prescribed doses of Prograf is crucial to ensure that it works effectively and reduces the chances of transplant rejection. Inconsistent intake can disrupt the balance of suppression. It has potential adverse effects.

Monitoring parameters during therapy

Monitoring the tacrolimus levels in the blood is essential to ensure it remains within the range and avoids toxicity. It is also necessary to assess both hepatic function due to the drug's known risks of causing kidney and liver damage. Additionally, monitoring levels is crucial to detect imbalances such as potassium or low magnesium.

Situations that require dosage adjustments

Careful adjustment of the dosage is necessary in situations where the drug is administered alongside CYP3A4 inhibitors when there are indications of graft rejection or when there are signs of drug toxicity.

Important Precautions

Recognizing early signs of complications

Recognizing signs of complications, such as increased creatinine levels, tremors, or high blood pressure, can help prevent adverse effects. This allows for intervention with treatments.

What to do in the event of a missed dose

If you accidentally miss a dose take it as soon as you realize.. If it's almost time, for your dose it's better to skip the missed one to avoid taking a double dose.

Long-term use considerations

Regular health checkups are essential when taking medication to prevent and identify risks like cancers, infections, or other complications caused by prolonged immune system suppression.

Administration to Special Populations

Administration to the Elderly

Dosage considerations

Elderly individuals may require starting doses due to their increased sensitivity to medication and potential impairment in organ functions.

Risks and monitoring

Elderly individuals need to be monitored for infections, cancers, and kidney problems due to their vulnerability.

Administration to Pregnant Women and Nursing Mothers

Known risks to the fetus

Prograf is categorized as a Class C drug, and studies on animals have shown effects on fetal development. However, its impact, on humans is still uncertain, so it is essential to evaluate the risks and benefits before using it during pregnancy.

Breastfeeding considerations and safety

Considering that Tacrolimus is eliminated through breast milk, it is essential for breastfeeding mothers who are taking Prograf to be informed about the risks, to their newborns and consider exploring feeding options.

Administration to Children

Age-specific dosage guidelines

Dosages for children, are usually adjusted based on their weight and the specific organs involved, which means that each child's medication needs to be tailored to their circumstances.

Monitoring pediatric patients

It is crucial to evaluate the growth parameters, developmental milestones, and renal function to ensure the drug's safety in children.


Recognizing symptoms of overdose

Excessive intake of Prograf can lead to symptoms such, as shaking, rapid heartbeat, high blood pressure, and impaired kidney function. It is essential to recognize these signs in order to prevent complications.

Immediate steps and treatment protocols

If someone overdoses, it is crucial to seek help. The treatment may involve providing care adjusting the dosage, and using hemodialysis to help remove the drug from the body quickly.

Long-term concerns and monitoring

After an overdose, it is essential to monitor patients for any indications of kidney damage, nerve damage, or other possible consequences.


Ideal storage conditions

Prograf should be kept in a dry place, at room temperature, away from direct sunlight and heat, to maintain its effectiveness as a medication.

Shelf life and expiry considerations

After the expiration date of Prograf, its effectiveness and safety may be uncertain. Patients need to remember to check the expiration dates and avoid using medications that have expired.

Disposal of expired or unused medication

It is essential to dispose of unnecessary Prograf in a manner. One should ideally use designated pharmaceutical disposal programs to avoid consumption or environmental contamination.

Handling Precautions

Proper handling to ensure efficacy

To ensure that Prograf remains effective it is essential to handle it with hands, store it in its packaging and take precautions to prevent any contamination.

Precautions to maintain sterility

When it comes to preparations, maintaining sterility is extremely important. Make sure to follow techniques when preparing and administering the medication, ensuring that the vial remains intact without any compromise, to its integrity.

Safeguards for caregivers and healthcare professionals

Caregivers and healthcare staff who are giving Prograf should wear gloves especially if they have any cuts or scrapes to avoid contact, with the medication and reduce the risk of adverse reactions.

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