Prograf oral and injection

Name: Prograf oral and injection

What is tacrolimus?

Tacrolimus lowers your body's immune system. The immune system helps your body fight infections. The immune system can also fight or "reject" a transplanted organ such as a liver or kidney. This is because the immune system treats the new organ as an invader.

Tacrolimus is used together with other medicines to prevent your body from rejecting a heart, liver, or kidney transplant.

The Astragraf XL and Envarsus XR brands of tacrolimus is generally not used for liver transplants.

Tacrolimus may also be used for purposes not listed in this medication guide.

What happens if I miss a dose?

For Prograf or Hecoria: Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

For Astragraf XL or Envarsus XR: If you are more than 14 hours late, skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Before taking this medicine

You should not use Prograf if you are allergic to tacrolimus or hydrogenated castor oil, or if you have used cyclosporine (Neoral, Sandimmune, Gengraf) within the past 24 hours.

Prograf may increase your risk of developing serious infection, lymphoma, or other cancers. Talk with your doctor about the risks and benefits of using this medicine.

Using Prograf may also increase your risk of developing skin cancer, especially if you are treated over long periods of time with drugs that weaken the immune system. Talk with your doctor about your specific risk.

Some people taking Prograf after a kidney transplant have developed diabetes. This effect has been seen most commonly in people who are Hispanic or African-American. Talk with your doctor about your individual risk of diabetes if you have concerns.

To make sure this medicine is safe for you, tell your doctor if you have:

  • kidney or liver disease;

  • heart disease, high blood pressure, high cholesterol or triglycerides (a type of fat in the blood);

  • a heart rhythm disorder or history of long QT syndrome;

  • if you take heart rhythm medication; or

  • if you use other medications that can weaken your immune system.

It is not known whether Prograf will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Tacrolimus can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using Prograf.

Prograf side effects

Get emergency medical help if you have any signs of an allergic reaction to Prograf: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur during treatment with Prograf. Stop using this medicine and call your doctor right away if you have signs of infection such as: sudden weakness or ill feeling, fever, chills, sweating, sore throat, painful mouth sores, skin warmth or redness, flu symptoms, muscle aches, cough, pale skin, easy bruising, or unusual bleeding.

Also call your doctor at once if you have:

  • general ill feeling, pain or swelling near your transplanted organ;

  • change in your mental state, problems with speech or walking, decreased vision (may start gradually and get worse quickly);

  • little or no urinating; painful or difficult urination; swelling in your feet or ankles;

  • headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;

  • high blood pressure - severe headache, blurred vision, pounding in your neck or ears, anxiety;

  • high blood sugar - increased thirst, increased urination, hunger, fruity breath odor, nausea, loss of appetite, drowsiness, blurred vision, confusion;

  • high potassium - slow heart rate, weak pulse, muscle weakness, tingly feeling;

  • low magnesium or phosphate - bone pain, jerky muscle movements, muscle weakness or limp feeling, slow reflexes;

  • nervous system problems - confusion, headache, vision problems, tremors, numbness and tingly feeling, seizure (convulsions); or

  • signs of stomach bleeding - bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Common Prograf side effects may include:

  • infections, high blood pressure, low phosphate, high potassium;

  • kidney problems, urination problems;

  • tremors or shaking, numbness or tingling;

  • nausea, diarrhea, constipation, stomach pain;

  • weakness, headache, general pain;

  • sleep problems (insomnia); or

  • swelling in your hands or feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Summary

Common side effects of Prograf include: diabetes mellitus, infection, headache, hyperglycemia, hyperkalemia, increased blood urea nitrogen, increased serum creatinine, mental status changes, nephrotoxicity, sensation disorder, and tremor. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to tacrolimus: oral capsule, oral capsule extended release, oral tablet extended release

Other dosage forms:

  • intravenous solution

Along with its needed effects, tacrolimus (the active ingredient contained in Prograf) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking tacrolimus:

More common
  • Abdominal or stomach pain
  • abnormal dreams
  • agitation
  • chills
  • confusion
  • convulsions (seizures)
  • diarrhea
  • dizziness
  • fever and sore throat
  • flu-like symptoms
  • frequent urination
  • headache
  • itching
  • loss of appetite
  • loss of energy or weakness
  • mental depression
  • muscle trembling or twitching
  • nausea
  • pale skin
  • seeing or hearing things that are not there
  • shortness of breath
  • skin rash
  • swelling of the feet or lower legs
  • tingling
  • trembling and shaking of the hands
  • trouble sleeping
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting
Less common
  • Blurred vision
  • chest pain
  • increased sensitivity to pain
  • muscle cramps
  • numbness or pain in the legs
  • ringing in the ears
  • sweating
Rare
  • Enlarged heart
  • flushing of the face or neck
  • general feeling of discomfort or illness
  • weight loss
Incidence not known
  • Black, tarry stools
  • blistering, peeling, loosening of the skin
  • bloating
  • bloody urine
  • constipation
  • cough
  • drowsiness
  • fainting
  • fast, slow, or irregular heartbeat
  • heartburn
  • increased thirst
  • indigestion
  • joint or muscle pain
  • lightheadedness
  • lower back or side pain
  • pinpoint red spots on the skin
  • pounding or rapid pulse
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • skin sores
  • ulcers or white spots in the mouth or on the lips
  • weakness
  • weight gain
  • yellow eyes or skin

Some side effects of tacrolimus may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Acid or sour stomach
  • belching
  • difficulty with moving
  • lack or loss of strength
  • muscle pain or stiffness
Less common
  • Body aches or pain
  • burning or stinging of the skin
  • cracks in the skin
  • crying
  • delusions
  • dementia
  • depersonalization
  • dysphoria
  • euphoria
  • excessive muscle tone
  • feeling of constant movement of self or surroundings
  • feeling that others are watching you or controlling your behavior
  • feeling that others can hear your thoughts
  • increased sensitivity of the skin to sunlight
  • large, flat, blue or purplish patches in the skin
  • loss of strength or energy
  • muscle tension or tightness
  • painful blisters on the trunk of the body
  • painful cold sores or blisters on the lips, nose, eyes, or genitals
  • paranoia
  • quick to react or overreact emotionally
  • rapidly changing moods
  • redness or other discoloration of the skin
  • restlessness
  • scaly skin
  • sensation of spinning
  • severe mood or mental changes
  • severe sunburn
  • sleepiness or unusual drowsiness
  • sore mouth or tongue
  • sores on the skin
  • swelling or inflammation of the mouth
  • tender, swollen glands in the neck
  • unusual behavior
  • white patches in the mouth, tongue, or throat
Incidence not known
  • Change in color vision
  • decreased weight
  • difficulty seeing at night
  • feeling hot and cold
  • hearing loss
  • sudden sweating

For Healthcare Professionals

Applies to tacrolimus: intravenous solution, oral capsule, oral capsule extended release, oral tablet extended release

General

Some of the most commonly reported side effects include hypertension, diarrhea, hyperglycemia, anemia, headache, tremor, insomnia, pain, and asthenia.[Ref]

Cardiovascular

Very common (10% or more): Hypertension (up to 89%), peripheral edema (up to 36%), chest pain (up to 19%), pericardial effusion (up to 15%)
Frequency not reported: Angina pectoris, bradycardia, cardiac fibrillation, cardiomyopathy, cardiopulmonary failure, deep thrombophlebitis, ECG abnormalities, echocardiogram abnormalities, heart rate decreased, hemorrhage, hypotension, myocardial hypertrophy, peripheral vascular disorder, phlebitis, QT prolongation, tachycardia, thrombosis, Torsade de Pointes, vasodilation[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (up to 72%), nausea (up to 46%), constipation (up to 36%), vomiting (up to 29%), dyspepsia (up to 28%)
Frequency not reported: Abdomen enlarged, duodenitis, dysphagia, esophagitis, flatulence, gastritis, gastroesophagitis, gastrointestinal (GI) hemorrhage, GI perforation, ileus, oral moniliasis, pancreatic pseudocyst, peritonitis, rectal disorder, stomatitis, ulcerative esophagitis[Ref]

Metabolic

Very common (10% or more): Hyperglycemia (up to 70%), hypophosphatemia (up to 49%), hypomagnesemia (up to 48%), hyperkalemia (up to 45%), anorexia (up to 34%), hyperlipidemia (up to 34%), hypokalemia (up to 29%)
Frequency not reported: Abnormal healing, acidosis, alkalosis, appetite increased, bicarbonate decreased, dehydration, gout, hypercalcemia, hypercholesterolemia, hyperphosphatemia, hyperuricemia, hypervolemia, hypocalcemia, hypoglycemia, hyponatremia, hypoproteinemia, lactic dehydrogenase increased, weight gain[Ref]

Hematologic

Very common (10% or more): Anemia (up to 65%), leukopenia (up to 48%), leukocytosis (up to 32%), thrombocytopenia (24%)
Frequency not reported: Coagulation disorder, ecchymosis, hematocrit increased, hemoglobin abnormal, hypochromic anemia, polycythemia, prothrombin decreased, serum iron decreased
Postmarketing reports: Agranulocytosis, disseminated intravascular coagulation, hemolytic anemia, hemolytic-uremic syndrome, neutropenia, pancytopenia, pure red cell aplasia, thrombocytopenic purpura, thrombotic thrombocytopenic purpura[Ref]

Nervous system

Very common (10% or more): Headache (up to 64%), tremor (up to 56%), paresthesia (up to 40%), dizziness (up to 19%), fatigue (up to 16%)
Frequency not reported: Amnesia, aphasia, convulsion, encephalopathy, hemorrhagic stroke, hypertonia, incoordination, monoparesis, myoclonus, nerve compression, nervousness, neuralgia, neuropathy, paralysis flaccid, psychomotor skills impaired, quadriparesis, seizures, somnolence, vertigo, writing impaired
Postmarketing reports: Coma, dysarthria, posterior reversible encephalopathy syndrome (PRES), progressive multifocal leukoencephalopathy (PML)[Ref]

Psychiatric

Very common (10% or more): Insomnia (up to 64%)
Frequency not reported: Abnormal dreams, agitation, anxiety, confusion, crying, depression, emotional lability, hallucinations, mental status changes, mood elevated, nightmares, psychosis, thinking abnormal
Postmarketing reports: Mutism[Ref]

Other

Very common (10% or more): Pain (up to 63%), asthenia (up to 54%), fever (up to 48%)
Frequency not reported: Abscess, accidental injury, chills, ear pain, fall, feeling abnormal, generalized edema, hernia, otitis media, sepsis, temperature intolerance, tinnitus, ulcer[Ref]

Renal

Very common (10% or more): Serum creatinine increased (up to 45%), BUN increased (up to 30%)
Frequency not reported: BK nephropathy, hydronephrosis, renal failure, toxic nephropathy, tubular necrosis[Ref]

Respiratory

Very common (10% or more): Pleural effusion (up to 36%), dyspnea (up to 29%), atelectasis (up to 28%), cough increased (18%), bronchitis (17%)
Frequency not reported: Asthma, emphysema, hiccups, lung disorder, pharyngitis, pneumonia, pneumothorax, pulmonary edema, rhinitis, sinusitis, voice changes
Postmarketing reports: Interstitial lung disease[Ref]

Hepatic

Very common (10% or more): Liver function tests abnormal (up to 36%)
Frequency not reported: Cholangitis, cholestatic jaundice, GGT increased, granulomatous hepatitis, hepatitis, jaundice[Ref]

Dermatologic

Very common (10% or more): Pruritus (up to 36%), rash (up to 24%)
Frequency not reported: Alopecia, cellulitis, hirsutism, photosensitivity, sweating[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection (up to 34%), oliguria (up to 19%)
Frequency not reported: Albuminuria, bladder spasm, cystitis, dysuria, hematuria, nocturia, pyuria, urge incontinence, urinary frequency, urinary incontinence, urinary retention, vaginitis[Ref]

Immunologic

Very common (10% or more): Cytomegalovirus infection (up to 12%)
Frequency not reported: Flu syndrome[Ref]

Oncologic

Postmarketing reports: Epstein-Barr virus associated lymphoproliferative disorder, hepatosplenic T-cell lymphoma, leukemia, lymphoma, melanoma, post-transplant lymphoproliferative disorder (PTLD)[Ref]

Musculoskeletal

Frequency not reported: Arthralgia, generalized spasm, joint disorder, leg cramps, mobility decreased, myasthenia, myalgia, osteoporosis
Postmarketing reports: Rhabdomyolysis[Ref]

Hypersensitivity

Frequency not reported: Allergic reaction[Ref]

Ocular

Frequency not reported: Abnormal vision, amblyopia[Ref]

Some side effects of Prograf may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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