Cyclosporine (Injection)

Cyclosporine (Injection)
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: Kiran Singh, M.D. [2]

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Black Box Warning

Warning: See full prescribing information for complete Boxed Warning. * Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe cyclosporine. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient. Cyclosporine should be administered with adrenal corticosteroids but not with other immunosuppressive agents. Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression.

Overview

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Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition1

• Dosing Information

• Dosage

Condition2

• Dosing Information

• Dosage

Condition3

• Dosing Information

• Dosage

Condition4

• Dosing Information

• Dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Cyclosporine (Injection) in adult patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Cyclosporine (Injection) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Cyclosporine (Injection) in pediatric patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

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

Contraindications

• Condition1

Warnings

Warning: See full prescribing information for complete Boxed Warning. * Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe cyclosporine. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient. Cyclosporine should be administered with adrenal corticosteroids but not with other immunosuppressive agents. Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression.

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Cyclosporine (Injection) in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Cyclosporine (Injection) in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Cyclosporine (Injection) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Cyclosporine (Injection) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Cyclosporine (Injection) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Cyclosporine (Injection) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Cyclosporine (Injection) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Cyclosporine (Injection) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Cyclosporine (Injection) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Cyclosporine (Injection) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Cyclosporine (Injection) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Cyclosporine (Injection) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Cyclosporine (Injection) in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Cyclosporine (Injection) in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Cyclosporine (Injection) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Cyclosporine (Injection) in the drug label.

Pharmacology

There is limited information regarding Cyclosporine (Injection) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Cyclosporine (Injection)01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Cyclosporine (Injection) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Cyclosporine (Injection) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Cyclosporine (Injection) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Cyclosporine (Injection) in the drug label.

How Supplied

Storage

There is limited information regarding Cyclosporine (Injection) 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 Patient Counseling Information of Cyclosporine (Injection) in the drug label.

Precautions with Alcohol

• Alcohol-Cyclosporine (Injection) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

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

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