Astagraf XL

1 What is Astagraf XL?

Brand: Astagraf XL, Envarsus XR, Hecoria, Prograf

Generic: Tacrolimus

Tacrolimus is an immunosuppressive agent that used to allow the body to accept a transplanted organ. This medicine may be used with steroids, azathioprine, basiliximab, or mycophenolate mofetil. Tacrolimus acts by weakening the body’s natural defense to prevent it from rejecting the transplanted organ. However, it can cause serious side effects such as kidney problems and infection.

This medicine is used for patients who undergone transplants as well as for patients with rheumatoid arthritis.

This product is available in capsule, extended release capsule, and extended release tablet.

2 What to Know Before Using

Tell to your doctor if you are allergic to tacrolimus or to any other medications.

Safety and effectiveness of this medication have not been established in children. Although this medicine have not demonstrated geriatric-specific problems, older patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving tacrolimus

Pregnancy C - The use of tacrolimus during pregnancy is warranted only if benefits justify risks to the fetus and only when no alternative management is appropriate.

There are no adequate studies whether tacrolimus can pass through breast milk or if it could cause harmful effects to the infant. Discuss with your doctor if you are breastfeeding a baby.

Taking tacrolimus with any of the following medications is not recommended. Your doctor may choose not to treat you with this medication or change some of the other medicines you take.

  • Amifampridine
  • Bepridil
  • Cisapride
  • Dronedarone
  • Mesoridazine
  • Mifepristone
  • Nelfinavir
  • Pimozide
  • Piperaquine
  • Posaconazole
  • Saquinavir
  • Sparfloxacin
  • Terfenadine
  • Thioridazine
  • Ziprasidone

Taking tacrolimus with any of the following medications is usually not recommended, but with exception in some cases. Your doctor may change the dose or how often you use one or both of the medicines if both medicines are prescribed together.

  • Aceclofenac
  • Acemetacin
  • Adalimumab
  • Afatinib
  • Alefacept
  • Alfuzosin
  • Amiodarone
  • Amitriptyline
  • Amlodipine
  • Amprenavir
  • Amtolmetin Guacil
  • Anagrelide
  • Apomorphine
  • Aprepitant
  • Aripiprazole
  • Arsenic Trioxide
  • Asenapine
  • Aspirin
  • Astemizole
  • Atazanavir
  • Azithromycin
  • Live Bacillus of Calmette and Guerin Vaccine
  • Bedaquiline
  • Blinatumomab
  • Boceprevir
  • Bosentan
  • Bromfenac
  • Bufexamac
  • Buserelin
  • Carbamazepine
  • Caspofungin
  • Celecoxib
  • Ceritinib
  • Chloroquine
  • Chlorpromazine
  • Choline Salicylate
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clomipramine
  • Clonixin
  • Clozapine
  • Cobicistat
  • Colchicine
  • Conivaptan
  • Crizotinib
  • Cyclobenzaprine
  • Cyclosporine
  • Dabrafenib
  • Dalfopristin
  • Darunavir
  • Dasabuvir
  • Dasatinib
  • Degarelix
  • Delamanid
  • Delavirdine
  • Desipramine
  • Deslorelin
  • Dexamethasone
  • Dexibuprofen
  • Dexketoprofen
  • Diclofenac
  • Diflunisal
  • Diltiazem
  • Dipyrone
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Donepezil
  • Doxepin
  • Droperidol
  • Droxicam
  • Ebastine
  • Echinacea
  • Efavirenz
  • Eliglustat
  • Enzalutamide
  • Eribulin
  • Erythromycin
  • Escitalopram
  • Esomeprazole
  • Etodolac
  • Etofenamate
  • Etoricoxib
  • Etravirine
  • Famotidine
  • Felbamate
  • Felbinac
  • Fenoprofen
  • Fepradinol
  • Feprazone
  • Fingolimod
  • Flecainide
  • Floctafenine
  • Flufenamic Acid
  • Fluoxetine
  • Flurbiprofen
  • Formoterol
  • Fosamprenavir
  • Fosaprepitant
  • Foscarnet
  • Fosphenytoin
  • Galantamine
  • Gatifloxacin
  • Gemifloxacin
  • Golimumab
  • Gonadorelin
  • Goserelin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Histrelin
  • Hydroquinidine
  • Hydroxychloroquine
  • Ibuprofen
  • Ibuprofen Lysine
  • Ibutilide
  • Idelalisib
  • Iloperidone
  • Imatinib
  • Imipramine
  • Indinavir
  • Indomethacin
  • Infliximab
  • Isavuconazonium Sulfate
  • Itraconazole
  • Ivabradine
  • Ketoconazole
  • Ketoprofen
  • Ketorolac
  • Lapatinib
  • Leuprolide
  • Levofloxacin
  • Lornoxicam
  • Loxoprofen
  • Lumacaftor
  • Lumefantrine
  • Lumiracoxib
  • Live Measles Virus Vaccine
  • Meclofenamate
  • Mefenamic Acid
  • Mefloquine
  • Meloxicam
  • Methadone
  • Metronidazole
  • Mibefradil
  • Mitotane
  • Mizolastine
  • Modafinil
  • Moricizine
  • Morniflumate
  • Moxifloxacin
  • Live Mumps Virus Vaccine
  • Nabumetone
  • Nafarelin
  • Naproxen
  • Nefazodone
  • Nepafenac
  • Nevirapine
  • Niflumic Acid
  • Nilotinib
  • Nimesulide
  • Norfloxacin
  • Octreotide
  • Ofloxacin
  • Olanzapine
  • Ombitasvir
  • Omeprazole
  • Ondansetron
  • Oxaprozin
  • Oxcarbazepine
  • Oxyphenbutazone
  • Paliperidone
  • Panobinostat
  • Parecoxib
  • Paritaprevir
  • Paroxetine
  • Pasireotide
  • Pazopanib
  • Pentamidine
  • Perflutren Lipid Microsphere
  • Perphenazine
  • Phenobarbital
  • Phenylbutazone
  • Phenytoin
  • Piketoprofen
  • Pipamperone
  • Piroxicam
  • Pixantrone
  • Live Poliovirus Vaccine
  • Prednisone
  • Primidone
  • Probucol
  • Procainamide
  • Prochlorperazine
  • Proglumetacin
  • Promethazine
  • Propafenone
  • Propionic Acid
  • Propyphenazone
  • Proquazone
  • Protriptyline
  • Quetiapine
  • Quinidine
  • Quinine
  • Quinupristin
  • Ranolazine
  • Rifabutin
  • Rifampin
  • Rilpivirine
  • Risperidone
  • Ritonavir
  • Rofecoxib
  • Live Rotavirus Vaccine
  • Live Rubella Virus Vaccine
  • Salicylic Acid
  • Salsalate
  • Schisandra sphenanthera
  • Secukinumab
  • Sertindole
  • Sevoflurane
  • Siltuximab
  • Sirolimus
  • Smallpox Vaccine
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Sodium Salicylate
  • Solifenacin
  • Sorafenib
  • Sotalol
  • St John's Wort
  • Sulindac
  • Sunitinib
  • Tamoxifen
  • Telaprevir
  • Telavancin
  • Telithromycin
  • Tenoxicam
  • Tetrabenazine
  • Tiaprofenic Acid
  • Tizanidine
  • Tocophersolan
  • Tolfenamic Acid
  • Tolmetin
  • Tolterodine
  • Toremifene
  • Trazodone
  • Trimipramine
  • Triptorelin
  • Typhoid Vaccine
  • Valdecoxib
  • Vandetanib
  • Vardenafil
  • Varicella Virus Vaccine
  • Vemurafenib
  • Venlafaxine
  • Verapamil
  • Vilanterol
  • Vinflunine
  • Voriconazole
  • Vorinostat
  • Yellow Fever Vaccine

Taking tacrolimus with any of the following medications may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. Your doctor may change the dose or the frequency of one or both of your medicines if both medicines are prescribed together.

  • Basic Aluminum Carbonate
  • Aluminum Hydroxide
  • Aluminum Phosphate
  • Chloramphenicol
  • Clotrimazole
  • Danazol
  • Dihydroxyaluminum Aminoacetate
  • Dihydroxyaluminum Sodium Carbonate
  • Ertapenem
  • Lansoprazole
  • Magnesium Carbonate
  • Magnesium Hydroxide
  • Magnesium Oxide
  • Magnesium Trisilicate
  • Metoclopramide
  • Nifedipine

Some medical conditions can interact with this medication. Tell your doctor if you have any of the following conditions:

Have a question aboutOrgan Transplantation?Ask a doctor now

3 Proper Usage

Take tacrolimus exactly as prescribed by your doctor. Excessive use of this medication will increase the chance for side effects while inadequate use may cause rejection of your transplanted organ.

You may take the immediate-release capsule with or without food. Take it at the same time every day.

For extended-release capsule user:

  • Swallow the capsule whole with liquid. Do not crush, break, chew, or divide it.
  • Take the medicine every morning on an empty stomach at least 1 hour before or at least 2 hours after breakfast.
  • You should not drink alcohol with the capsule.

For extended-release tablet user:

  • Take it on an empty stomach at the same time every morning.
  • Take the tablet whole with water. Do not crush, chew, or break it.
  • You should not drink alcohol with the tablet.

Recommended dosage for tacrolimus capsule in different age groups:

  • Prophylactic management for heart transplant rejection:
    • Adults—Dose is based on body weight and must be determined by your doctor. Starting dose is usually 0.075 milligram per kilogram of body weight per day, divided into two doses and taken every 12 hours. Your doctor may change the dose as necessary.
    • Children—Use and dose must be determined by your doctor.
  • Prophylactic management for transplant rejection:
    • Adults—Dose is based on body weight and must be determined by your doctor. Starting dose is usually 0.1 to 0.2 milligram per kilogram of body weight per day, divided into two doses and taken every 12 hours. Your doctor may change the dose as needed.
    • Children—Use and dose must be determined by your doctor.
  • Prophylactic management for liver transplant rejection:
    • Adults and children 16 years of age and older—Dose is based on body weight and must be determined by your doctor. Starting dose is usually 0.1 to 0.15 milligram per kilogram of body weight per day, divided into two doses and taken every 12 hours. Your doctor may change the dose as needed.
    • Children younger than 16 years of age—Dose is based on body weight and must be determined by your doctor. Starting dose is usually 0.15 to 0.2 mg per kg of body weight per day, divided into two doses and taken every 12 hours. Your doctor may change the dose as needed.

Recommended dosage for tacrolimus extended-release capsules in different age groups:

  • Prophylactic management for kidney transplant rejection:
    • Adults and children 16 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually between 0.1 to 0.2 milligram per kilogram of body weight per day given as a single dose. Your doctor may change the dose as needed.
    • Children younger than 16 years of age—Use and dose must be determined by your doctor.

Recommended dosage for tacrolimus extended-release tablets in different age groups:

  • Prophylactic management for kidney transplant rejection:
    • Adults—One tablet once a day, every morning.
    • Children—Use and dose must be determined by your doctor.

Do not eat grapefruit or drink grapefruit juice while you are taking this medicine because this will increase the amount of medicine in the body.

Do not stop using this medication without telling your physician. You may be required to take this medicine for the rest of your life to prevent your body from rejecting the transplant.

If you miss a dose of Astagraf XL™ or Envarsus XR and it is not more than 14 hours since the regular schedule, take the missed dose as soon as possible. However, if more than 14 hours have passed since the regular time, skip the missed dose and start again to your regular dosing schedule.

Store the medication in a closed container at room temperature, away from heat, moisture, and direct light. Keep out of reach of children. Do not keep expired medications.

4 Precautions to Take

Your doctor will be checking you regularly for the effectiveness of the medication. Blood tests may be ordered as well for undesirable effects.

Tacrolimus may increase your risk of getting skin cancer or cancer of the lymph system. Use sunscreen or sunblock lotions with a SPF of at least 15 on a regular basis when you are outside the house. You should wear hats and use umbrella. Keep out of direct sunlight.

Tacrolimus may lower your immune system. Do proper hand hygiene and avoid coming into close contact with sick people. You may use a face mask for added protection. Tell your doctor if you have any kind of infection.

Do not receive any vaccinations without your doctor’s approval while you are under tacrolimus treatment to prevent the risk of getting an infection. Furthermore, avoid people who have received live virus vaccines to prevent the chance of getting the virus.

Taking this medication may increase your risk of having a rare and serious virus infection with the BK polyoma virus. Check with your doctor immediately if you are having more than one of these symptoms: bloody urine, a decreased frequency or amount of urine, increased thirst, swelling of the face, loss of appetite, weight gain, lower back or side pain/fingers/lower legs, breathing difficulty, unusual tiredness or weakness, nausea, or vomiting.

The use of tacrolimus may increase your risk of developing progressive multifocal leukoencephalopathy. Check with your doctor immediately if you are having more than one of these symptoms: clumsiness, vision changes, loss of coordination, confusion, memory loss, difficulty speaking or understanding what others say, or weakness in the legs.

The use of tacrolimus may increase your risk for gastrointestinal perforation. Talk to your doctor if you have concerns about this matter.

Taking this medicine may cause dangerous nervous system problems. Tell your doctor immediately if you have the following symptoms while using this medicine: high blood pressure, blurred vision, headache, mental changes, dizziness, seizures, or a fast heartbeat.

This medicine may cause hyperkalemia. Check with your doctor immediately if you have abdominal or stomach pain, difficulty with breathing, confusion, an irregular heartbeat, nervousness, nausea or vomiting, numbness or tingling in the hands, feet, or lips, or weakness or heaviness of the legs.

This medicine may cause a pure red cell aplasia. Check with your doctor immediately if you have a fever and sore throat, pale skin, unusual bleeding or bruising, or unusual tiredness or weakness.

Talk to your doctor if you are taking any other medication.

5 Potential Side Effects

If any of the following side effects occur, check with your doctor right away:

  • Abdominal or stomach pain
  • Abnormal dreams
  • Agitation
  • Chills
  • Confusion
  • Convulsions
  • 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
  • Blurred vision
  • Chest pain
  • Increased sensitivity to pain
  • Muscle cramps
  • Numbness or pain in the legs
  • Ringing in the ears
  • Sweating
  • Enlarged heart
  • Flushing of the face or neck
  • General feeling of discomfort or illness
  • Weight loss
  • 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

Less serious side effects:

  • Acid or sour stomach
  • Belching
  • Difficulty with moving
  • Lack or loss of strength
  • Muscle pain or stiffness
  • 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
  • Change in color vision
  • Decreased weight
  • Difficulty seeing at night
  • Feeling hot and cold
  • Hearing loss
  • Sudden sweating

Not all side effects are listed above. If you notice any other effects, check with your healthcare professional.

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