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Uptravi

Last reviewed on RxList: 8/19/2020
Uptravi Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Uptravi?

Uptravi (selexipag) is a prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH.

What Are Side Effects of Uptravi?

Common side effects of Uptravi include:

Dosage for Uptravi

The starting dose of Uptravi is 200 mcg twice daily. Increase the dose of Uptravi by 200 mcg twice daily at weekly intervals to the highest tolerated dose up to 1600 mcg twice daily.

What Drugs, Substances, or Supplements Interact with Uptravi?

Uptravi may interact with strong inhibitors of CYP2C8 (e.g., gemfibrozil). Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or become pregnant while using Uptravi. Uptravi is not recommended for use while breastfeeding.

Uptravi During Pregnancy and Breastfeeding

Our Uptravi (selexipag) tablets Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

COPD (chronic obstructive pulmonary disease) is the same as adult-onset asthma. See Answer
Uptravi Professional Information

SIDE EFFECTS

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of UPTRAVI has been evaluated in a long-term, placebo-controlled study enrolling 1156 patients with symptomatic PAH (GRIPHON study) [see Clinical Studies]. The exposure to UPTRAVI in this trial was up to 4.2 years with median duration of exposure of 1.4 years.

Table 1 presents adverse reactions more frequent on UPTRAVI than on placebo by ≥3%.

Table 1 Adverse Reactions

Adverse Reaction UPTRAVI Placebo
N=575 N=577
Headache 65% 32%
Diarrhea 42% 18%
Jaw pain 26% 6%
Nausea 33% 18%
Myalgia 16% 6%
Vomiting 18% 9%
Pain in extremity 17% 8%
Flushing 12% 5%
Arthralgia 11% 8%
Anemia 8% 5%
Decreased appetite 6% 3%
Rash 11% 8%

These adverse reactions are more frequent during the dose titration phase.

Hyperthyroidism was observed in 1% (n=8) of patients on UPTRAVI and in none of the patients on placebo.

Laboratory Test Abnormalities

Hemoglobin

In a Phase 3 placebo-controlled study in patients with PAH, mean absolute changes in hemoglobin at regular visits compared to baseline ranged from −0.34 to −0.02 g/dL in the selexipag group compared to −0.05 to 0.25 g/dL in the placebo group. A decrease in hemoglobin concentration to below 10 g/dL was reported in 8.6% of patients treated with selexipag and 5.0% of placebo-treated patients.

Thyroid Function Tests

In a Phase 3 placebo-controlled study in patients with PAH, a reduction (up to −0.3 MU/L from a baseline median of 2.5 MU/L) in median thyroid-stimulating hormone (TSH) was observed at most visits in the selexipag group. In the placebo group, little change in median values was apparent. There were no mean changes in triiodothyronine or thyroxine in either group.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of Uptravi. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Symptomatic hypotension

Read the entire FDA prescribing information for Uptravi (Uptravi Selexipag Tablets)

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Related Health

© Uptravi Patient Information is supplied by Cerner Multum, Inc. and Uptravi Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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