Revatio

REVATIO- sildenafil citrate tablet, film coated
REVATIO- sildenafil citrate injection, solution
REVATIO- sildenafil citrate powder, for suspension
Pfizer Laboratories Div Pfizer Inc

1 INDICATIONS AND USAGE

REVATIO is indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when REVATIO was added to background epoprostenol therapy [see Clinical Studies (14)].

Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II–III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%).

Limitation of Use: Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity [see Clinical Studies (14)].

2 DOSAGE AND ADMINISTRATION

2.1 REVATIO Tablets and Oral Suspension

The recommended dose of REVATIO is 5 mg or 20 mg three times a day. Administer REVATIO doses 4–6 hours apart.

In the clinical trial no greater efficacy was achieved with the use of higher doses. Treatment with doses higher than 20 mg three times a day is not recommended.

2.2 REVATIO Injection

REVATIO injection is for the continued treatment of patients with PAH who are currently prescribed oral REVATIO and who are temporarily unable to take oral medication.

The recommended dose is 2.5 mg or 10 mg administered as an intravenous bolus injection three times a day. The dose of REVATIO injection does not need to be adjusted for body weight.

A 10 mg dose of REVATIO injection is predicted to provide pharmacological effect of sildenafil and its N-desmethyl metabolite equivalent to that of a 20 mg oral dose.

2.3 Reconstitution of the Powder for Oral Suspension

Note: Reconstitute the contents of the bottle with a total volume of 90 mL (60 mL followed by 30 mL). Refer to the detailed instructions below.

  1. Tap the bottle to release the powder.
  2. Remove the cap.
  3. Accurately measure out 60 mL of water and pour the water into the bottle. (Figure 1)
    Figure 1
    (click image for full-size original)

    Figure 1

  4. Replace the cap and shake the bottle vigorously for a minimum of 30 seconds. (Figure 2)
    Figure 2
    (click image for full-size original)

    Figure 2

  5. Remove the cap.
  6. Accurately measure out another 30 mL of water and add this to the bottle. You should always add a total of 90 mL of water irrespective of the dose prescribed. (Figure 3)
    Figure 3
    (click image for full-size original)

    Figure 3

  7. Replace the cap and shake the bottle vigorously for a minimum of 30 seconds. (Figure 4)
    Figure 4
    (click image for full-size original)

    Figure 4

  8. Remove the cap.
  9. Press the bottle adaptor into the neck of the bottle (as shown on Figure 5, below). The adaptor is provided so that you can fill the oral syringe with medicine from the bottle. Replace the cap on the bottle.
    Figure 5
    (click image for full-size original)

    Figure 5

  10. Write the expiration date of the reconstituted oral suspension on the bottle label (the expiration date of the reconstituted oral suspension is 60 days from the date of reconstitution).
Figure 1Figure 2Figure 3Figure 4Figure 5

Incompatibilities

Do not mix with any other medication or additional flavoring agent.

3 DOSAGE FORMS AND STRENGTHS

REVATIO Tablets

White, film-coated, round tablets engraved with “RVT20” containing sildenafil citrate equivalent to 20 mg of sildenafil.

REVATIO Injection

Single use vial containing 10 mg/12.5 mL of sildenafil.

REVATIO for Oral Suspension

White to off-white powders containing 1.57 g of sildenafil citrate (equivalent to 1.12 g of sildenafil) in a bottle intended for reconstitution. Following reconstitution with 90 mL of water, the volume of the oral suspension is 112 mL and the oral suspension contains 10 mg/mL sildenafil. A 2 mL oral syringe (with 0.5 mL and 2 mL dose markings) and a press-in bottle adaptor are also provided.

4 CONTRAINDICATIONS

REVATIO is contraindicated in patients with:

  • Concomitant use of organic nitrates in any form, either regularly or intermittently, because of the greater risk of hypotension [see Warnings and Precautions (5.2)].
  • Concomitant use of riociguat, a guanylate cyclase stimulator. PDE-5 inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat.
  • Known hypersensitivity to sildenafil or any component of the tablet, injection, or oral suspension. Hypersensitivity, including anaphylactic reaction, anaphylactic shock and anaphylactoid reaction, has been reported in association with the use of sildenafil.

5 WARNINGS AND PRECAUTIONS

5.1 Mortality with Pediatric Use

In a long-term trial in pediatric patients with PAH, an increase in mortality with increasing REVATIO dose was observed. Deaths were first observed after about 1 year and causes of death were typical of patients with PAH. Use of REVATIO, particularly chronic use, is not recommended in children [see Use in Specific Populations (8.4)].

5.2 Hypotension

REVATIO has vasodilatory properties, resulting in mild and transient decreases in blood pressure. Before prescribing REVATIO, 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 [BP 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 REVATIO.

5.3 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 REVATIO to patients with veno-occlusive disease, administration of REVATIO to such patients is not recommended. Should signs of pulmonary edema occur when REVATIO is administered, consider the possibility of associated PVOD.

5.4 Epistaxis

The incidence of epistaxis was 13% in patients taking REVATIO with PAH secondary to CTD. This effect was not seen in idiopathic PAH (REVATIO 3%, placebo 2%) patients. The incidence of epistaxis was also higher in REVATIO-treated patients with a concomitant oral vitamin K antagonist (9% versus 2% in those not treated with concomitant vitamin K antagonist).

The safety of REVATIO is unknown in patients with bleeding disorders or active peptic ulceration.

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