Tacrolimus .5 mg/1
Tacrolimus · CAPSULE · BPI Labs LLC
Tacrolimus is a prescription medication taken by mouth that helps prevent the body's immune system from rejecting transplanted organs. It works by suppressing immune function to allow transplanted tissue to survive in the recipient.
Key Facts
- Brand Name
- Tacrolimus
- Generic Name
- Tacrolimus
- NDC Code (Product)
54288-134- Manufacturer
- BPI Labs LLC
- Strength
- .5 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA206651
- Marketing Start
- 04/08/2020
Recall History
Aidapak Services, LLC
Labeling: Label Mixup: TACROLIMUS, Capsule, 1 mg may have potentially been mislabeled as one of the following drugs: BISOPROLOL FUMARATE, Tablet, 5 mg, NDC 29300012601, Pedigree: AD34934_7, EXP: 5/10/2014; SEVELAMER CARBONATE, Tablet, 800 mg, NDC 58468013001, Pedigree: AD56917_4, EXP: 5/21/2014; SEVELAMER CARBONATE, Tablet, 800 mg, NDC 58468013001, Pedigree: AD73627_11, EXP: 5/30/2014; ATOMOXE
Pharmacy Innovations
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Mylan Pharmaceuticals Inc.
Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles.
Western Drug
Lack of Assurance of Sterility
Valor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy
Subpotent drug
Aidapak Services, LLC
Labeling: Label Mixup; TACROLIMUS, Capsule, 1 mg may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 125 mcg, NDC 00074706890, Pedigree: AD70633_4, EXP: 5/23/2014.
American Pharmaceutical Ingredients LLC
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Martin Avenue Pharmacy, Inc.
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Astellas Pharma US Inc.
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Reliable Rexall-A Compounding Pharmacy
Lack of Processing Controls
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Tacrolimus extended-release capsules is indicated for the prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants in adult patients who can swallow capsules intact [see Clinical Studies ( 14.1 ), ( 14.2 )] . Pediatric use information is approved for Astellas Pharma US, Inc.'s ASTAGRAF XL (tacrolimus extended-release capsules). However, due to Astellas Pharma US, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information. Tacrolimus extended-release capsules is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants in adult patients who can swallow capsules intact. ( 1 , 14.1 , 14.2 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Capsules must be taken whole. ( 2.1 ) Take consistently every morning at the same time on an empty stomach at least 1 hour before a meal or at least 2 hours after a meal. ( 2.1 ) Avoid eating grapefruit or drinking grapefruit juice or alcohol. ( 2.1 ) African-American patients and patients with severe hepatic impairment may require dosing adjustments. ( 2.3 ) Frequent monitoring of trough concentrations is recommended. ( 2.4 ) For complete dosing information, see Full Prescribing Information. MMF = Mycophenolate mofetil Recommended Tacrolimus Extended-Release Capsules Initial Dosage Patient Population Initial Oral Dosage Whole Blood Trough Concentration Range ADULT With basiliximab, MMF and steroids 0.15 mg/kg to 0.2 mg/kg once daily prior to reperfusion or within 48 hours of completion of transplant Month 1: 7 ng/mL to 15 ng/mL Month 2 to Month 6: 5 ng/mL to 15 ng/mL More than 6 Months: 5 ng/mL to 10 ng/mL With MMF and steroids, without basiliximab induction First dose (pre-operative): 0.1 mg/kg, within 12 hours prior to reperfusion Subsequent doses (post-operative): 0.2 mg/kg once daily at least 4 hours after pre-operative dose and within 12 hours afte…
Contraindications
4 CONTRAINDICATIONS Tacrolimus extended-release capsules is contraindicated in patients with known hypersensitivity to tacrolimus [see Adverse Reactions ( 6.2 )] . Known hypersensitivity to tacrolimus. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Risk of rejection with strong CYP3A inducers and risk of serious adverse reactions with strong CYP3A inhibitors: Adjust dose and monitor tacrolimus concentrations. ( 2.4 , 5.10 , 7.2 ) Therapeutic drug monitoring and dose reduction for tacrolimus extended-release capsules should be considered when tacrolimus extended-release capsules is co-administered with cannabidiol. ( 2.4 , 5.15 , 7.3 ) See Full Prescribing Information for clinically significant drug interactions. ( 7.1 , 7.2 , 7.3 ) 7.1 Mycophenolic Acid When tacrolimus extended-release capsules is prescribed with a given dose of a mycophenolic acid (MPA) product, exposure to MPA is higher with tacrolimus extended-release capsules co-administration than with cyclosporine co-administration with MPA, because cyclosporine interrupts the enterohepatic recirculation of MPA while tacrolimus does not. Monitor for MPA-associated adverse reactions and reduce the dose of concomitantly administered mycophenolic acid products as needed. 7.2 Effects of Other Drugs on Tacrolimus Extended-Release Capsules Table 5 displays the effects of other drugs on tacrolimus extended-release capsules. Table 5: Effects of Other Drugs/S…
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse drug reactions are discussed in greater detail in other sections of labeling: Lymphoma and Other Malignancies [see Warnings and Precautions ( 5.1 )] Serious Infections [see Warnings and Precautions ( 5.2 )] Increased Mortality in Female Liver Transplant Patients [see Warnings and Precautions ( 5.3 )] New Onset Diabetes after Transplant [see Warnings and Precautions ( 5.5 )] Nephrotoxicity due to Tacrolimus Extended-Release Capsules and Drug Interactions [see Warnings and Precautions ( 5.6 )] Neurotoxicity [see Warnings and Precautions ( 5.7 )] Hyperkalemia [see Warnings and Precautions ( 5.8 )] Hypertension [see Warnings and Precautions ( 5.9 )] QT Prolongation [see Warnings and Precautions ( 5.11 )] Pure Red Cell Aplasia [see Warnings and Precautions ( 5.13 )] Thrombotic Microangiopathy, Including Hemolytic Uremic Syndrome and Thrombotic Thrombocytopenic Purpura [see Warnings and Precautions (5.14) ] The most common adverse reactions (≥ 30%) are: diarrhea, constipation, nausea, peripheral edema, tremor and anemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact eVenus Pharmaceutical Laboratories, Inc. at 1-609…
Frequently Asked Questions
What is Tacrolimus used for?
Tacrolimus is a prescription medication taken by mouth that helps prevent the body's immune system from rejecting transplanted organs. It works by suppressing immune function to allow transplanted tissue to survive in the recipient.
Is Tacrolimus a controlled substance?
Tacrolimus is not classified as a controlled substance by the DEA.
What is the generic name for Tacrolimus?
The generic name for Tacrolimus is Tacrolimus. There are 1 other brand versions of Tacrolimus.
What is the NDC code for Tacrolimus .5 mg/1?
The NDC (National Drug Code) for Tacrolimus .5 mg/1 is 54288-134, listed by BPI Labs LLC.