What is a Generic Drug?
A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
Astagraf XL (Tacrolimus)
Also Known as Advagraf ER (Tacrolimus)
Prescription Required
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Product Details
Description
Astagraf XL (tacrolimus extended-release capsules) is prescribed with other medications to help prevent organ rejection in patients who have undergone a kidney transplant.
Astagraf XL is available in 0.5 mg, 1 mg, and 5 mg oral capsules.
Fact Table
Formula
C44H69NO12
License
US FDA
Bioavailability
~20% (oral)
Legal status
Prescription only (Rx)
Chemical Name
Tacrolimus
Elimination half-life
12 hours
Dosage (Strength)
0.5 mg, 1 mg, 5 mg extended-release capsules
Pregnancy
Consult a doctor
Brands
Astagraf XL, Prograf (immediate-release form)
Protein binding
~99%
PubChem CID
445643
MedlinePlus
a601117
ChEBI
CHEBI:5311
ATC code
L04AD02
DrugBank
DB00864
KEGG
D00408
Routes of administration
Oral
Directions
Take Astagraf XL (tacrolimus) capsules exactly as prescribed by your doctor, who will determine an appropriate treatment regimen for you.
Your dose will be based on your weight and other treatments. Take the capsules whole and at the same time every morning on an empty stomach. Do not consume grapefruit, grapefruit juice, or alcohol.
Keep Astagraf XL stored at 25°C (77°F).
For further instructions for use, refer to the medication guide that accompanies your prescription.
If you have any questions or concerns about Astagraf XL, talk to your doctor or pharmacist.
Ingredients
The active ingredient in Astagraf XL is tacrolimus.
Inactive ingredients include ethylcellulose NF, hypromellose USP, magnesium stearate NF, lactose monohydrate NF, gelatin NF, titanium dioxide USP, ferric oxide NF, and sodium lauryl sulfate.
Contraindications
Patients who are allergic to tacrolimus should not take Astagraf XL.
Cautions
- Astagraf XL is contains the following FDA Boxed Warning:
- Serious infection and malignancy risks that may result in hospitalization or death are increased with Astagraf XL
- Astagraf XL increases mortality in female liver transplant patients and therefore, is not approved for use in liver transplantation
- Before you begin taking Astagraf XL, talk to your doctor about:
- All the prescription and over-the-counter medications you take
- Your allergies
- Your current health problems and past medical history
- Your pregnancy or breastfeeding status
- Astagraf XL is associated with the following warnings and precautions:
- Astagraf XL is not interchangeable with other tacrolimus products
- Diabetes can develop
- Kidney problems
- Neurological problems
- High potassium levels in the blood
- High blood pressure
- Prolongation of the QT interval, a type of abnormal heart rhythm
- Live vaccines should be avoided
- Pure red cell aplasia
- Thrombotic microangiopathy (hemolytic uremic syndrome and thrombotic thrombocytopenic purpura)
Side Effects
Constipation, diarrhea, nausea, swelling, anemia, and tremor are common side effects associated with Astagraf XL; however, other side effects can also occur. Immediately notify your doctor about any side effects that bother you or won’t go away.
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Reference
Astagraf XL. Northbrook, IL: Astellas Pharma US, Inc.; 2023.
IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.Product Code : 13789
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