Prograf

The active ingredient in Prograf is tacrolimus, which is a calcineurin inhibitor. It functions as an immunosuppressant, reducing the activity of your immune system to ensure that your body does not reject the new organ.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide, before using Prograf. However, the following is a synopsis of the general guidelines for the use of Prograf:

• Tacrolimus formulations differ in terms of direction and age cut-offs. If you (or your child) are just starting or transitioning to a different formulation of tacrolimus, double-check with your doctor that the formulation, dosage, and recommendations are correct. Do not move from one formulation to another without your doctor's approval, since this can result in serious adverse effects.
• Take Prograf and your other post-transplant medications at the same time every day. This reduces the chance of negative effects and ensures that the treatments are effective for you.
• Swallow the capsules and tablets whole. Do not cut, smash, or chew them. If you have difficulty swallowing, consult your doctor about using Prograf oral granules.
• Avoid drinking grapefruit or Seville orange juices (commonly known as bitter or sour oranges) while taking Prograf.
• Avoid live immunisations, such as the nasal spray flu vaccine, while taking Prograf. This can increase your risk of infection from the immunisation.

The most common side effects of Prograf include:

• High blood pressure.
• Tremor.
• Changes in electrolyte levels.
• Increased risk of infection.
• Constipation.
• Higher creatine levels.
• Nausea or vomiting.
• Headache.
• Diarrhea.
• Feeling weak.
• Loss of appetite.
• Trouble sleeping.
• Low red blood cell count.
• Joint pain, chest pain, or stomach pain.
• Low magnesium or phosphate levels.

Some individuals may experience serious side effects while using Prograf. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Abnormal cardiac rhythm (QT prolongation) symptoms include chest pounding, difficulty breathing, chest pain, and a sense of fainting or lightheadedness.
• Serious infections include fever, cough, chills, sore throat, runny or stuffy nose, and body aches.
• Low blood cell counts include difficult-to-stop bleeding, vomiting blood, blood in the urine or stool, and "coffee-ground" stool.
• Heart attack symptoms include chest pain, stomach discomfort, perspiration, nausea, and dizziness.
• Stroke symptoms include sudden numbness or weakness in the arm, leg, or face, confusion, vision problems, headaches, and difficulty walking.
• Sudden kidney injury symptoms include feeling unwell or weak, dehydration, peeing less than normal, confusion, blood in the urine, and swelling in the legs, ankles, or feet.
• Nerve disorders include seizures, tremors, headaches, disorientation, and pins and needles.

These are not all of the possible side effects of Prograf. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Prograf, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including whether you have:

• Kidney problems or a history of kidney disease
• High blood sugar or diabetes
• High blood pressure
• Neurological conditions, including a history of seizures or stroke
• Any known heart problems, such as heart enlargement or irregular rhythms
• High potassium levels
• A weakened immune system or recent infections
• A history of allergic reactions to injectable medications
• Plans to receive any vaccines, especially live vaccines
• A history of anemia or blood disorders
• Any use of sirolimus or other transplant medications

Boxed Warning

Tacrolimus increases the risk of serious infections and certain cancers, including lymphoma and skin cancer, which can be life-threatening. Higher death rates were also seen in female liver transplant patients using the extended-release form, so it's not recommended for that use. Only experienced healthcare providers should prescribe and manage this medication, ideally in specialised settings equipped to monitor transplant patients closely.

Tacrolimus has caused adverse reactions in the past.

History of adverse reaction to polyoxyl 60 hydrogenated castor oil (HCO-60) if taking the Prograf injection.

Tacrolimus acts slowly, and it can take up to 12 weeks to take effect.

When Prograf is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Amiodarone.
• Cyclosporine.
• Clarithromycin.
• Ketoconazole.
• Voriconazole.
• Amphotericin B.
• Caspofungin.
• Cisplatin.
• Ganciclovir.
• Grapefruit juice.
• Itraconazole.
• Rifabutin.
• Rifampin.
• Fluconazole.
• Ritonavir.
• Letermovir.
• Certain heart or blood pressure medications, like diuretics (water pills).

Your tacrolimus (Prograf) dose will be determined by your weight, ethnicity, kidney or liver health, transplant type, and other immunosuppressants you are taking.

Liver transplant

Adults: The typical starting dose is 0.1 mg to 0.15 mg/kg body weight daily, divided into two doses and taken orally twice a day.

Children: The normal dose is 0.15 mg to 0.2 mg/kg of body weight daily, divided into two doses and taken orally twice a day.

Heart and lung transplants.

Generic IR pills and Prograf alone: Prograf is used for heart and lung transplants. Generic IR capsules are only for cardiac transplants.

Adults: The typical starting dose is 0.075 mg/kg body weight daily, divided into two doses and taken orally twice a day.

Children: The typical starting dose is 0.3 mg/kg body weight daily, divided into two doses and administered orally twice daily.

Kidney transplant

Adults

IR with Prograf: The average initial dose is 0.1 mg to 0.2 mg/kg of body weight daily, divided into two doses and given orally twice a day.

Astagraf XL: The typical starting dose is 0.1 mg to 0.2 mg/kg body weight taken orally once a day in the morning.

Children

Astagraf XL: The typical starting dose is 0.3 mg/kg body weight taken orally once a day in the morning.

Prograf: The typical starting dose is 0.3 mg/kg body weight daily, divided into two doses and given orally twice a day.

Store at room temperature and keep out of reach of children.

Astellas Pharma is the company that manufactures Prograf.

There are lower-cost generic versions available of Prograf.

You should never stop taking Prograf without consulting your doctor first. Because it is an immunosuppressant intended to prevent organ rejection, abruptly discontinuing it can result in catastrophic complications, including organ rejection.

Tell your doctor if you are pregnant or plan to get pregnant. Tacrolimus may harm an unborn baby and can worsen conditions such as diabetes or high blood pressure in the mother.

Tacrolimus has been reported to be present in breast milk, but its effects are not known. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.