July 28, 2015
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Opsumit

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Opsumit

Warnings
Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Embryo-fetal Toxicity

OPSUMIT may cause fetal harm when administered during pregnancy and is contraindicated for use in females who are pregnant. In females of reproductive potential, exclude pregnancy prior to initiation of therapy, ensure use of acceptable contraceptive methods and obtain monthly pregnancy tests [see DOSAGE AND ADMINISTRATION and Use in Specific Populations].

OPSUMIT is available for females through the OPSUMIT REMS Program, a restricted distribution program [see OPSUMIT REMS Program].

OPSUMIT REMS Program

For all females, OPSUMIT is available only through a restricted program called the OPSUMIT REMS Program, because of the risk of embryo-fetal toxicity [see CONTRAINDICATIONS, Embryo-fetal Toxicity, and Use In Specific Populations].

Notable requirements of the OPSUMIT REMS Program include the following:

  • Prescribers must be certified with the program by enrolling and completing training.
  • All females, regardless of reproductive potential, must enroll in the OPSUMIT REMS Program prior to initiating OPSUMIT. Male patients are not enrolled in the REMS.
  • Females of reproductive potential must comply with the pregnancy testing and contraception requirements [see Use in Specific Populations].
  • Pharmacies must be certified with the program and must only dispense to patients who are authorized to receive OPSUMIT.

Further information is available at www.OPSUMITREMS.com or 1-866-228-3546. Information on OPSUMIT certified pharmacies or wholesale distributors is available through Actelion Pathways at 1-866-228-3546.

Hepatotoxicity

Other ERAs have caused elevations of aminotransferases, hepatotoxicity, and liver failure. The incidence of elevated aminotransferases in the study of OPSUMIT in PAH is shown in Table 1.

Table 1 : Incidence of Elevated Aminotransferases in the SERAPHIN Study

  OPSUMIT 10 mg
(N=242)
Placebo
(N=249)
> 3 x ULN 3.4% 4.5%
> 8 x ULN 2.1% 0.4%

In the placebo-controlled study of OPSUMIT, discontinuations for hepatic adverse events were 3.3% in the OPSUMIT 10 mg group vs. 1.6% for placebo. Obtain liver enzyme tests prior to initiation of OPSUMIT and repeat during treatment as clinically indicated.

Advise patients to report symptoms suggesting hepatic injury (nausea, vomiting, right upper quadrant pain, fatigue, anorexia, jaundice, dark urine, fever, or itching). If clinically relevant aminotransferase elevations occur, or if elevations are accompanied by an increase in bilirubin > 2 ULN, or by clinical symptoms of hepatotoxicity, discontinue OPSUMIT. Consider re-initiation of OPSUMIT when hepatic enzyme levels normalize in patients who have not experienced clinical symptoms of hepatotoxicity.

Hemoglobin Decrease

Decreases in hemoglobin concentration and hematocrit have occurred following administration of other ERAs and were observed in clinical studies with OPSUMIT. These decreases occurred early and stabilized thereafter. In the placebo-controlled study of OPSUMIT in PAH, OPSUMIT 10 mg caused a mean decrease in hemoglobin from baseline to up to 18 months of about 1.0 g/dL compared to no change in the placebo group. A decrease in hemoglobin to below 10.0 g/dL was reported in 8.7% of the OPSUMIT 10 mg group and in 3.4% of the placebo group. Decreases in hemoglobin seldom require transfusion. Initiation of OPSUMIT is not recommended in patients with severe anemia. Measure hemoglobin prior to initiation of treatment and repeat during treatment as clinically indicated [see ADVERSE REACTIONS].

Pulmonary Edema With Pulmonary Veno-occlusive Disease (PVOD)

Should signs of pulmonary edema occur, consider the possibility of associated PVOD. If confirmed, discontinue OPSUMIT.

Decreased Sperm Counts

Other ERAs have caused adverse effects on spermatogenesis. Counsel men about potential effects on fertility [see Use in Specific Populations and Nonclinical Toxicology].

Patient Counseling Information

See FDA-approved patient labeling (Medication Guide).

Embryo-Fetal Toxicity

Instruct patients on the risk of fetal harm when OPSUMIT is used in pregnancy [see WARNINGS AND PRECAUTIONS and Use in Specific Populations]. Instruct females of reproductive potential to use effective contraception and to contact her physician if they suspect they may be pregnant. Female patients must enroll in the OPSUMIT REMS program.

OPSUMIT REMS Program

For female patients, OPSUMIT is available only through a restricted program called the OPSUMIT REMS Program [see WARNINGS AND PRECAUTIONS]. Male patients are not enrolled in the OPSUMIT REMS.

Inform female patients (and their guardians, if applicable) of the following notable requirements.

  • Female patients must sign an enrollment form.
  • Female patients of reproductive potential must comply with the pregnancy testing and contraception requirements [see Use in Specific Populations].

Educate and counsel females of reproductive potential on the use of emergency contraception in the event of unprotected sex or contraceptive failure.

Advise pre-pubertal females to report any changes in their reproductive status immediately to her prescriber.

Review the Medication Guide and REMS educational materials with female patients.

Decrease in Hemoglobin

Advise patients on the importance of hemoglobin testing.

Hepatotoxicity

Some members of this pharmacological class are hepatotoxic. Educate patients on signs of hepatotoxicity. Advise patients that they should contact their doctor if they have unexplained nausea, vomiting, right upper quadrant pain, fatigue, anorexia, jaundice, dark urine, fever, or itching.

Administration

Patients should be advised not to split, crush, or chew tablets.

Last reviewed on RxList: 5/14/2015
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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