Tacrolimus (extended release)

Tacrolimus (extended release)
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Shivani Chaparala M.B.B.S [2]

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Black Box Warning

WARNING See full prescribing information for complete Boxed Warning. MALIGNANCIES AND SERIOUS INFECTIONS INCREASED RISK FOR DEVELOPING SERIOUS INFECTIONS AND MALIGNANCIES WITH ENVARSUS XR OR OTHER IMMUNOSUPPRESSANTS THAT MAY LEAD TO HOSPITALIZATION OR DEATH.

Overview

Tacrolimus (extended release) is a calcineurin-inhibitor immunosuppressant that is FDA approved for the prophylaxis of organ rejection in kidney transplant patients converted from tacrolimus immediate-release formulations in combination with other immunosuppressants.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include (incidence ≥10%) diarrhea and blood creatinine increased..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

There is limited information regarding Tacrolimus (extended release) FDA-Labeled Indications and Dosage (Adult) in the drug label.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Tacrolimus (extended release) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Tacrolimus (extended release) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Tacrolimus (extended release) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Tacrolimus (extended release) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Tacrolimus (extended release) in pediatric patients.

Contraindications

There is limited information regarding Tacrolimus (extended release) Contraindications in the drug label.

Warnings

WARNING See full prescribing information for complete Boxed Warning. MALIGNANCIES AND SERIOUS INFECTIONS INCREASED RISK FOR DEVELOPING SERIOUS INFECTIONS AND MALIGNANCIES WITH ENVARSUS XR OR OTHER IMMUNOSUPPRESSANTS THAT MAY LEAD TO HOSPITALIZATION OR DEATH.

There is limited information regarding Tacrolimus (extended release) Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Tacrolimus (extended release) Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Tacrolimus (extended release) Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Tacrolimus (extended release) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Tacrolimus (extended release) in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Tacrolimus (extended release) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Tacrolimus (extended release) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Tacrolimus (extended release) in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Tacrolimus (extended release) in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Tacrolimus (extended release) in geriatric settings.

Gender

There is no FDA guidance on the use of Tacrolimus (extended release) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Tacrolimus (extended release) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Tacrolimus (extended release) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Tacrolimus (extended release) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Tacrolimus (extended release) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Tacrolimus (extended release) in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Tacrolimus (extended release) Administration in the drug label.

Monitoring

There is limited information regarding Tacrolimus (extended release) Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Tacrolimus (extended release) and IV administrations.

Overdosage

There is limited information regarding Tacrolimus (extended release) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Tacrolimus (extended release) Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Tacrolimus (extended release) Mechanism of Action in the drug label.

Structure

There is limited information regarding Tacrolimus (extended release) Structure in the drug label.

Pharmacodynamics

There is limited information regarding Tacrolimus (extended release) Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Tacrolimus (extended release) Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Tacrolimus (extended release) Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Tacrolimus (extended release) Clinical Studies in the drug label.

How Supplied

There is limited information regarding Tacrolimus (extended release) How Supplied in the drug label.

Storage

There is limited information regarding Tacrolimus (extended release) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Tacrolimus (extended release) Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Tacrolimus (extended release) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Tacrolimus (extended release) Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Tacrolimus (extended release) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.