Cost and Insurance Coverage for Liquid Sildenafil

Hazard ratio estimates from the proportional Hazards model, stratified by actual previous PAH treatment and etiology of PAH.

• Liquid sildenafil citrate is often compounded by pharmacies for personalized doses.
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Kaplan-Meier estimates of survival at 3 years were 66%, 79%, and 85% in the 5-, 20-, and 80- mg TID dose groups, respectively.

Medication Class	Interaction Type	Effect	Clinical Significance	Management Strategy
Nitrates	Additive hypotensive effect	Severe hypotension	High	Do not co-administer
Alpha-blockers	Increased blood pressure lowering	Dizziness, fainting	Moderate	Monitor blood pressure, dose adjustment
CYP3A4 Inhibitors	Increased sildenafil levels	Risk of side effects	High	Dose reduction or avoid concurrent use
Other PDE5 inhibitors	Additive effects	Prolonged or intensified vasodilation	Moderate	Caution, monitor for adverse events

Sildenafil 80 mg was also superior to 5 mg for time to first event of clinical worsening with HR (99.7% CI) = 0.44 (0.22, 0.89).

4. Contraindications

Of the total 229 patients who received sildenafil, there were 55, 74, and 100 patients in the low, medium, and high dose groups, respectively. Across the short-term and long-term studies, the overall duration of treatment from start of double-blind for individual patients ranged from 3 to 3,129 days. By sildenafil treatment group, median duration of sildenafil treatment was 1,696 days (excluding the 5 patients who received placebo in double-blind and were not treated in the long-term extension study). Peak VO2 was assessed 1 year after the start of the placebo-controlled study. Of sildenafil-treated patients developmentally able to perform the CPET 59/114 patients (52%) had not shown any deterioration in PVO2 from start of sildenafil.

J Urol

Similarly, 191 of 229 patients (83%) who had received sildenafil had either maintained or improved their WHO Functional Class at 1 year Kaplan-Meier estimates of survival at 3 years in patients > 20 kg in weight at baseline were 94%, 93%, and 85% in the low, medium, and high dose groups, respectively; for patients ≤ 20 kg in weight at baseline, the survival estimates were 94% and 93% for patients in the medium and high dose groups, respectively [see Use in Specific Populations (8.4) and Adverse Reactions (6.1)]. Study A1481324 (NCT02060487) - Study to Assess the Effects of Sildenafil on Mortality in Adults with PAH A study to assess the effects of multiple doses of sildenafil on mortality in adults with PAH was conducted following the observation of a higher risk of mortality in pediatric patients taking a high dose of sildenafil TID, based on body weight, compared to those taking a lower dose of sildenafil in the long-term extension of the pediatric clinical trial. The study was a randomized, double-blind, parallel-group study in 385 adults with PAH. Patients were randomly assigned 1:1:1 to one of three treatment groups (5, 20, and 80 mg TID). Most patients were PAH treatment naïve (83%).

Raynaud's phenomenon

For most patients the etiology of PAH was idiopathic (72%). The most common WHO Functional Class was Class III (58% of patients). Treatment groups were well balanced with respect to baseline demographics of strata history of PAH treatment and etiology of PAH, as well as the WHO Functional Class categories. The primary objective of the study was to compare sildenafil 80 mg TID versus 5 mg TID for mortality, with success defined by ruling out twice the mortality at 80 mg. The key secondary efficacy endpoint was time to first event of clinical worsening, defined as a composite endpoint of all-cause mortality, hospitalization for worsening PAH or disease progression. Hazard Ratios for Time to First Event of Clinical Worsening – Intent To Treat Population Note: Sildenafil 5 mg is not an approved dosage.

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Abbreviations: 6MWD = 6-minute walk distance; CI = confidence interval; PAH = pulmonary arterial hypertension. Clinical worsening events were defined as reduction from baseline in the 6MWD test by at least 15% and worsening functional class from baseline, both confirmed by a second test/evaluation within 2 weeks.

Detection in biological fluids

Treatment Allocation by Dose and Body Weight in Pediatric Study The proportion of patients receiving supportive medicinal products at baseline (anticoagulants, digoxin, calcium channel blockers, diuretics and/or oxygen) was similar in the combined sildenafil treatment group (48%) and the placebo treatment group (42%). The primary endpoint was a percentage change in VO2peak from baseline to week 16 assessed by CPET. Mean baseline peak volume of oxygen consumed (VO2) values were similar across the sildenafil treatment groups (17 to 18 mL/kg/min), and slightly higher for the placebo treatment group (20 mL/kg/min). A total of 45% of patients were evaluable for CPET, which comprised those children ≥ 7 years old and developmentally able to perform the test. Children < 7 years were evaluable only for the secondary endpoints.

Sildenafil Oral Suspension Dosage and Administration

Mean increases in VO2peak percentage change from baseline at Week 16, were observed with all 3 sildenafil doses (range of 6% to 13%, Figure 6), with little change with placebo (0.5%). Percentage Change from Baseline in sildenafil oral solution VO2Peak: Mean (95% Confidence Intervals) The estimated difference between the combined sildenafil doses and placebo was 8% (95% CI: - 0.2 to 16). The results of the main analysis (combined dose groups versus placebo) were not statistically significant (p = 0.056). The estimated difference between the sildenafil medium dose group and placebo was 11 ± 5% (95% CI: 2 to 21). Dose related improvements were observed with PVRI and mPAP.

Incidence not known

Statistically significant PVRI reductions compared to placebo were seen with the sildenafil medium and high dose groups (18% [95% CI: -32% to -2%] and 27% [95% CI: -39% to -14%], respectively) but not the low dose group (2% (95% CI: -20%, 20%). The sildenafil medium and high dose groups displayed mPAP changes from baseline compared to placebo, of -3.5 mmHg (95% CI: -8.9, 1.9) and -7.3 mmHg (95% CI: -12.4, -2.1), respectively; while the low dose group showed little difference from placebo (difference of 1.6 mmHg [95% CI: -4.5, 7.6]). Improvements were observed with cardiac index with all three sildenafil groups over placebo, 10%, 4%, and 15% for the low, medium, and high dose groups, respectively [see Clinical Pharmacology (12.2)]. STARTS-2 (NCT00159874) - Long-Term Survival with Oral Sildenafil Monotherapy in Treatment-Naïve Pediatric Pulmonary Arterial Hypertension Of the 234 pediatric patients treated in the short-term, placebo-controlled study, 220 patients entered the long-term extension study. Patients who had been in the placebo group in the shortterm study were randomly reassigned to sildenafil treatment; patients weighing ≤ 20 kg entered the medium or high dose groups (1:2), while patients weighing > 20 kg entered the low, medium, or high dose groups (1:1:1). Count of cases of disease progression as the first event of clinical worsening.

Medical uses

An additional secondary endpoint was 6MWD at Months 6 and 12. At the time of a planned interim analysis (50% deaths) it was identified that the primary efficacy objective of this protocol was met and therefore the study was stopped. Based on the primary efficacy endpoint (mortality), the non-inferiority of sildenafil 80 mg TID arm versus 5 mg TID arm was met using a 2-sided significance level of 0.003 for the interim analysis. Primary comparison of the 80 mg TID group to the 5 mg TID group yielded the HR (99.7% CI) = 0.51 (0.22, 1.21); i.e., non-inferiority was established. Hazard Ratios for Overall Survival, Assessed in the Proportional Hazards Model – Intent To Treat Population On treatment deaths: Any death within 7 days of last dose was regarded as sildenafil price ireland “On treatment”, thus might include deaths occurred after discontinuation from study treatment. c. Count of non-elective hospital stays for worsening PAH as the first event of clinical worsening.

• The liquid form of sildenafil citrate is often prescribed for patients with swallowing difficulties.
• It provides quicker onset of action compared to traditional tablets.
• Some formulations are designed for sublingual or buccal absorption.
• This form allows for flexible dosing, especially in clinical settings.
• It should be kept out of reach of children and pets.
• Do not mix liquid sildenafil with other medications unless advised.
• Usage instructions often recommend shaking the bottle before use.
• This medication works by relaxing blood vessels in the penis.
• It should only be used under medical supervision to avoid interactions.
• Overdose can lead to severe side effects like vision changes.
• Consult a doctor for proper dosage and whether this form is suitable.

d. Count of deaths as the first event of clinical worsening.

Condition	Risk Factors	Advice	Alternative Treatment
Use with Nitrates	Severe hypotension risk	Avoid combination	Psychotherapy, Other ED meds
Cardiovascular Disease	Increased cardiac stress	Consult cardiologist	Lifestyle modifications
Retinal Disorders	Worsening of existing visual issues	Medical evaluation needed	Other PDE5 inhibitors
Liver or Kidney Impairment	Altered drug metabolism	Dose adjustment or avoidance	Non-pharmacological options

e.

• Liquid sildenafil citrate is a water-based solution of the erectile dysfunction medication.
• It is often used for faster absorption compared to pills.
• This liquid form allows adjustable dosing for precise treatment.
• It is typically stored in a sealed bottle to prevent spoilage.
• The liquid is usually flavored to improve taste and ease consumption.
• It must be measured accurately with a dosing syringe or dropper.
• Not all brands are FDA approved; verify quality before use.
• Liquid sildenafil citrate may have a shorter shelf life than tablet forms.
• It’s important to consult a healthcare provider before use.
• Possible side effects include headaches, flushing, and dizziness.
• Store the liquid in a cool, dry place away from sunlight.

Hazard ratio estimates from the proportional Hazards model, stratified by actual previous PAH treatment and etiology of PAH.

References (18)

More than twice as many sildenafil-treated patients (36%) as placebo-treated patients (14%) showed an improvement in at least one functional New York Heart Association (NYHA) class for PAH. Study A1481243 (NCT00323297) - Sildenafil Added to Bosentan Therapy – Lack of Effect on Exercise Capacity A randomized, double-blind, placebo-controlled study was conducted in 103 patients with PAH who were on bosentan therapy for a minimum of 3 months. The PAH patients included those with primary PAH and PAH associated with CTD. Patients were randomized to placebo or sildenafil (20 mg three times a day) in combination with bosentan (62.5 to 125 mg twice a day). The primary efficacy endpoint was the change from baseline at Week 12 in 6-minute walk distance (6MWD).

12.2 Pharmacodynamics

The results indicate that there is no significant difference in mean change from baseline on 6MWD observed between sildenafil 20 mg plus bosentan and bosentan alone. STARTS-1 (NCT00159913) - Sildenafil in Treatment-Naive Children, Aged 1 to 17 Years, with Pulmonary Arterial Hypertension A total of 234 patients with PAH aged 1 to 17 years were treated in a randomized, double-blind, multi-center, placebo-controlled parallel group, dose-ranging study. Patients (38% male and 62% female) had body weight ≥ 8 kg and had idiopathic pulmonary arterial hypertension (33%), or PAH associated with congenital heart disease (systemic-to-pulmonary shunt 37%, surgical repair 30%). In this trial, 27% of patients were < 7 years old. Patients were WHO Functional Class I (32%), II (51%), III (15%), or IV (0.4%).

Dosage Forms and Strengths

Patients were naïve for specific PAH therapy and the use of prostacyclin, prostacyclin analogues and endothelin receptor antagonists were not permitted in the study, and neither were arginine supplementation, nitrates, alpha-blockers and potent CYP450 3A4 inhibitors. The primary objective of the study was to assess the effect of sildenafil on percent change from baseline in PVO2, normalized to body weight, from baseline to week 16 as measured by the Cardiopulmonary Exercise Test (CPET) (patients who were developmentally able to perform the test, n = 115). Secondary endpoints included hemodynamic monitoring, symptom assessment, WHO Functional Class, change in background treatment, and quality of life measurements (n = 234). Patients were allocated to one of three sildenafil treatment groups (low, medium, or high) or placebo. Actual doses administered were dependent on body weight (see Table 5). At baseline, the median of 6MWD for the intent-to-treat (ITT) population was 332 to 352 m.

Brand Name	Manufacturer	Concentration	Packaging	Price Range (USD)	Availability	Notes
SildeVape Liquid	PharmaTech Ltd.	20 mg/30 ml	30 ml bottle	$15-$25	Global	Approved for oral use
VidiVigo Liquid	MedicaPharma	25 mg/30 ml	30 ml bottle	$18-$28	Europe, Asia	Flavored options available
LiquidSild	BioMed Inc.	20 mg/30 ml	30 ml bottle	$20-$30	North America	Prescription only
SildenafilSolution	HealthMed Co.	20 mg/30 ml	30 ml bottle	$10-$20	Various markets	Generic versions available