UPTRAVI SIDE EFFECTS

Generic Name: uptravi selexipag tablets
Brand Name: Uptravi
Drug Class: PAH, Prostacyclin Agonists

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 11/5/2021

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). 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
Adverse Reaction	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.

SRC: NLM .

Jump To