Liqrev
(sildenafil citrate)Dosage & Administration
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Liqrev Prescribing Information
Adults
LIQREV is indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [see Clinical Studies (14)].
Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) tablets. However, because of Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information.
Recommended Dosage in Adults
The recommended dosage of LIQREV is 20 mg orally three times a day [see Clinical Studies (14). A calibrated measuring device is recommended to measure and deliver the prescribed dose accurately. Shake well for at least 10 seconds before use.
Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) tablets. However, because of Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information.
Oral Suspension: 10 mg/mL; white to off-white opaque suspension with a strawberry flavor. Each 1 mL of oral suspension contains 10 mg sildenafil (equivalent to 14 mg sildenafil citrate).
Pregnancy
Risk Summary
Limited published data from randomized controlled trials, case-controlled trials, and case series do not report a clear association with sildenafil and major birth defects, miscarriage, or adverse maternal or fetal outcomes when sildenafil is used during pregnancy. There are risks to the mother and fetus from untreated pulmonary arterial hypertension (see Clinical Considerations). Animal reproduction studies conducted with sildenafil showed no evidence of embryo-fetal toxicity or teratogenicity at doses up to 32- and 65-times the recommended human dose (RHD) of 20 mg three times a day in rats and rabbits, respectively (see Data).
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Clinical Considerations
Disease-Associated Maternal and/or Embryo/Fetal Risk
Pregnant women with untreated pulmonary arterial hypertension are at risk for heart failure, stroke, preterm delivery, and maternal and fetal death.
Data
Animal Data
No evidence of teratogenicity, embryotoxicity, or fetotoxicity was observed in pregnant rats or rabbits dosed with sildenafil 200 mg/kg/day during organogenesis, a level that is, on a mg/m2 basis, 32- and 65-times, respectively, the recommended human dose (RHD) of 20 mg three times a day. In a rat pre- and postnatal development study, the no‑observed-adverse-effect dose was 30 mg/kg/day (equivalent to 5-times the RHD on a mg/m2 basis).
Lactation
Risk Summary
Limited published data from a case report describe the presence of sildenafil and its active metabolite in human milk. There is insufficient information about the effects of sildenafil on the breastfed infant and no information on the effects of sildenafil on milk production. Limited clinical data during lactation preclude a clear determination of the risk of LIQREV to an infant during lactation.
Pediatric Use
The safety and effectiveness of LIQREV have not been established in pediatric patients younger than 1 year of age.
Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) tablets. However, because of Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information.
Geriatric Use
Clinical studies of sildenafil did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see Clinical Pharmacology (12.3)].
Patients with Hepatic Impairment
No dose adjustment for mild to moderate impairment is required. Severe impairment has not been studied [see Clinical Pharmacology (12.3)].
Patients with Renal Impairment
No dose adjustment is required (including severe impairment CLcr <30 mL/min) [see Clinical Pharmacology (12.3)].
LIQREV is contraindicated in patients with:
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- Concomitant use of organic nitrates in any form, either regularly or intermittently, because of the greater risk of hypotension [see Warnings and Precautions (5.1)].
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- Concomitant use of riociguat, a guanylate cyclase stimulator. Phosphodiesterase-5 (PDE-5) inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat.
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- Known hypersensitivity to sildenafil or any component of the oral suspension. Hypersensitivity, including anaphylactic reaction, anaphylactic shock and anaphylactoid reaction, has been reported in association with the use of sildenafil.
Hypotension
LIQREV has vasodilatory properties, resulting in mild and transient decreases in blood pressure. Before prescribing LIQREV, carefully consider whether patients with certain underlying conditions could be adversely affected by such vasodilatory effects (e.g., patients on antihypertensive therapy or with resting hypotension [blood pressure less than 90/50], fluid depletion, severe left ventricular outflow obstruction, or autonomic dysfunction). Monitor blood pressure when co‑administering blood pressure lowering drugs with LIQREV.
Worsening Pulmonary Vascular Occlusive Disease
Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno‑occlusive disease (PVOD). Since there are no clinical data on administration of LIQREV to patients with veno‑occlusive disease, administration of LIQREV to such patients is not recommended. Should signs of pulmonary edema occur when LIQREV is administered, consider the possibility of associated PVOD.
Epistaxis
The incidence of epistaxis was 13% in patients taking LIQREV with PAH secondary to CTD. This effect was not seen in idiopathic PAH (Sildenafil 3%, placebo 2%) patients. The incidence of epistaxis was also higher in Sildenafil-treated patients with a concomitant oral vitamin K antagonist (9% versus 2% in those not treated with concomitant vitamin K antagonist).
The safety of LIQREV is unknown in patients with bleeding disorders or active peptic ulceration.
Visual Loss
When used to treat erectile dysfunction, non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported post marketing in temporal association with the use of PDE-5 inhibitors, including sildenafil. Most patients had underlying anatomic or vascular risk factors for developing NAION, including low cup to disc ratio (“crowded disc”).
Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking LIQREV.
There are no controlled clinical data on the safety or efficacy of LIQREV in patients with retinitis pigmentosa, a minority of whom have genetic disorders of retinal phosphodiesterases. Therefore, use of LIQREV in patients with retinitis pigmentosa is not recommended.
Hearing Loss
Cases of sudden decrease or loss of hearing, which may be accompanied by tinnitus and dizziness, have been reported in temporal association with the use of PDE-5 inhibitors, including LIQREV. In some of the cases, medical conditions and other factors were reported that may have played a role. In many cases, medical follow-up information was limited. It is not possible to determine whether these reported events are related directly to the use of LIQREV, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors.
Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking PDE-5 inhibitors, including LIQREV.
Combination with Other PDE-5 inhibitors
Sildenafil is also marketed as VIAGRA®. The safety and efficacy of combinations of LIQREV with VIAGRA or other PDE-5 inhibitors have not been studied. Inform patients taking LIQREV not to take VIAGRA or other PDE-5 inhibitors.
Priapism
Use LIQREV with caution in patients with anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, or Peyronie’s disease) or in patients who have conditions, which may predispose them to priapism (e.g., sickle cell disease, multiple myeloma, or leukemia). In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism (painful erection greater than 6 hours in duration) is not treated immediately, penile tissue damage and permanent loss of potency could result.
Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell Disease
In a small, prematurely terminated study of patients with pulmonary hypertension (PH) secondary to sickle cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported by patients who received Sildenafil than by those randomized to placebo. The effectiveness and safety of LIQREV in the treatment of PH secondary to sickle cell disease has not been established.