Uptravi
- Generic Name: uptravi selexipag tablets
- Brand Name: Uptravi
- Drug Class: PAH, Prostacyclin Agonists
Uptravi (Uptravi Selexipag Tablets) side effects drug center
- Related Drugs
- Health Resources
- headache,
- diarrhea,
- jaw pain,
- nausea,
- muscle pain,
- vomiting,
- pain in extremities,
- flushing (warmth, redness, or tingly feeling),
- joint pain,
- low levels of iron in the blood (anemia),
- decreased appetite, or
- rash
- low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or
- new lung problems--anxiety, sweating, pale skin, severe shortness of breath, wheezing, gasping for breath, cough with foamy mucus, chest pain, fast or uneven heart rate.
- headache;
- jaw pain;
- muscle pain, pain in your arms or legs;
- nausea, vomiting, diarrhea; or
- flushing (warmth, redness, or tingly feeling).
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.
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
Common side effects may include:
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.
Read the entire detailed patient monograph for Uptravi (Uptravi Selexipag Tablets)
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
DRUG INTERACTIONS
CYP2C8 Inhibitors
Concomitant administration with gemfibrozil, a strong inhibitor of CYP2C8, doubled exposure to selexipag and increased exposure to the active metabolite by approximately 11-fold. Concomitant administration of UPTRAVI with strong inhibitors of CYP2C8 (e.g., gemfibrozil) is contraindicated [see CONTRAINDICATIONS and CLINICAL PHARMACOLOGY].
Although not studied, use of UPTRAVI with moderate CYP2C8 inhibitors (e.g., teriflunomide and deferasirox) can be expected to increase exposure to the active metabolite of selexipag. Consider a less frequent dosing regimen, e.g., once-daily, when initiating UPTRAVI in patients on a moderate CYP2C8 inhibitor. Reduce UPTRAVI when a moderate CYP2C8 inhibitor is initiated.
CYP2C8 Inducers
Concomitant administration with an inducer of CYP2C8 and UGT 1A3 and 2B7 enzymes (rifampin) halved exposure to the active metabolite. Increase dose up to twice of UPTRAVI when co-administered with rifampin. Reduce UPTRAVI when rifampin is stopped [see CLINICAL PHARMACOLOGY].
Read the entire FDA prescribing information for Uptravi (Uptravi Selexipag Tablets)
© 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.