Consumer medicine information

1. Why am I using VELETRI?

VELETRI contains the active ingredient epoprosterol sodium. VELETRI is used to treat some types of pulmonary arterial hypertension (PAH).
For more information, see Section 1. Why am I using VELETRI? in the full CMI.

2. What should I know before I use VELETRI?

Do not use if you have ever had an allergic reaction to epoprostenol sodium or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use VELETRI? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with VELETRI and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use VELETRI?

• VELETRI is intended for intravenous infusion into a vein.

• Your doctor or nurse will show you how to prepare VELETRI and how to administer it if you are using VELETRI at home.

5. What should I know while using VELETRI?

6. Are there any side effects?

Common side effects which have been reported include flushing, headache, dizziness, pain, jaw, muscle and/or back pain, joint pain, muscle tremors, increased body movement, nausea or vomiting, diarrhoea, wind or tummy discomfort, loss of appetite, facial flushing or paleness, itchy skin rash (eczema) or hives, decreased or increased feeling or sensitivity (especially in the skin), ulcer (sore) on the skin, sweating, dry mouth, fatigue, feeling very tired, anxiety, nervousness and agitation, fast or slow heart rate, fever, chills or flu-like symptoms.
If you experience an allergic reaction (symptoms include wheezing, difficulty in breathing, swelling of the lips/mouth/tongue, hay fever, lumpy rash (“hives”) and fainting) go to the Emergency Department of your nearest hospital immediately.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Epoprostenol (as sodium).

2 Qualitative and Quantitative Composition

The reconstituted solution of Veletri has a pH of 10.8 to 12.0 and is increasingly unstable at a lower pH. Its pKa value is 4.8.
One vial of sterile, lyophilised powder containing 0.531 mg epoprostenol sodium equivalent to 0.5 mg epoprostenol.
One vial of sterile, lyophilised powder containing 1.593 mg epoprostenol sodium equivalent to 1.5 mg epoprostenol.
See Section 6.1 List of Excipients.

3 Pharmaceutical Form

Powder for injection.
Veletri is a white to off-white powder that must be reconstituted with either sterile water for injection or with sodium chloride 0.9% solution for injection.
Veletri for Injection is a sterile product, formulated for intravenous administration.

4 Clinical Particulars

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).
In general, events seen after overdosage of epoprostenol represent exaggerated pharmacological effects of the drug (e.g. hypotension and complications of hypotension). Signs and symptoms of excessive doses of epoprostenol during clinical trials are the expected dose limiting pharmacologic effects of epoprostenol, including flushing, headache, hypotension, tachycardia, nausea, vomiting and diarrhoea. If overdosage occurs reduce the dose or discontinue the infusion and initiate appropriate supportive measures as necessary; for example plasma volume expansion and/or adjustment to pump flow.

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Epoprostenol was negative in an in vitro assay of gene mutation and in an in vitro assay of DNA damage. However, the instability of epoprostenol in solutions used for these assays makes the significance of these tests uncertain. Epoprostenol was negative in an in vivo assay of chromosomal damage (micronucleus tests in rats).
Carcinogenicity. Long-term studies in animals have not been performed to evaluate the carcinogenic potential of epoprostenol.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Epoprostenol (PGI2, PGX, prostacyclin) is (5Z,9α,11α,13E,15S)-6,9-epoxy-11,15-dihydroxyprosta-5,13-dien-1-oic acid, sodium salt.
Chemical structure. The structural formula of epoprostenol sodium is:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSEPOPRO.gif Molecular formula: C₂₀H₃₁NaO₅.
Relative molecular mass: 374.45.
Epoprostenol CAS Registry Number: 35121-78-9.
CAS number. 61849-14-7.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/VELETRST.gif