SUMMARY CMI

CARBOPROST-REACH

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using CARBOPROST-REACH?

CARBOPROST-REACH contains the active ingredient carboprost trometamol. CARBOPROST-REACH is used to stop excessive bleeding in women who have just given birth, when bleeding is due to the womb failing to return to its normal size.

For more information, see Section 1. Why am I using CARBOPROST-REACH? in the full CMI.

2. What should I know before I use CARBOPROST-REACH?

Do not use if you have ever had an allergic reaction to CARBOPROST-REACH 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 CARBOPROST-REACH? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with CARBOPROST-REACH 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. What should I know while using CARBOPROST-REACH?

For more information, see Section 5. What should I know while using CARBOPROST-REACH? in the full CMI.

5. Are there any side effects?

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.

FULL CMI

CARBOPROST-REACH

Active ingredient(s): carboprost trometamol

Consumer Medicine Information (CMI)

This leaflet provides important information about using CARBOPROST-REACH. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using CARBOPROST-REACH.

Where to find information in this leaflet:

1. Why am I using CARBOPROST-REACH?
2. What should I know before I use CARBOPROST-REACH?
3. What if I am taking other medicines?
4. How do I use CARBOPROST-REACH?
5. What should I know while using CARBOPROST-REACH?
6. Are there any side effects?
7. Product details

1. Why am I using CARBOPROST-REACH?

CARBOPROST-REACH contains the active ingredient carboprost (as trometamol). CARBOPROST-REACH belongs to a group of medicines called prostaglandins. Prostaglandins are hormone-like substances produced naturally in your body. They act to increase the contractions of your womb and helps control bleeding after you have given birth to your baby.

CARBOPROST-REACH is used to stop excessive bleeding in women who have just given birth, when bleeding is due to the womb failing to return to its normal size.

2. What should I know before I use CARBOPROST-REACH?

Warnings

Do not use CARBOPROST-REACH if:

• you are allergic to carboprost (as trometamol), or any of the ingredients listed at the end of this leaflet.
• Always check the ingredients to make sure you can use this medicine.

Check with your doctor if you:

• have any other medical conditions such as
  - an infection of your womb, ovaries or fallopian tubes (this may be causing pain in your pelvis or vaginal discharge)
  - any problems with your heart, lung, kidney or liver
• are currently taking other similar medicines to help control your contractions and bleeding.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Do not have this medicine if you are pregnant.

CARBOPROST-REACH contains an ingredient called benzyl alcohol (see list of ingredients at the end of this leaflet), that can cross the placenta. Benzyl alcohol has been associated with serious side effects which can be fatal in children, especially premature and low weight infants. CARBOPROST-REACH should only be given shortly after you have delivered your baby and not while you are still pregnant as it could put the embryo or foetus at risk.

Tell your doctor, nurse or other healthcare provider if you intend to breastfeed your baby.

It is not known if CARBOPROST-REACH is excreted in human breast milk.

You must wait for at least 6 hours after receiving your last dose of CARBOPROST-REACH before breastfeeding your baby.

Do not give this medicine to children.

Tell your doctor, nurse or other healthcare provider if you have or have had any of the following medical conditions:

• lung disease, including asthma
• high or low blood pressure (including high blood pressure in pregnancy)
• heart disease or anaemia (low blood count)
• kidney or liver disease (including jaundice)
• glaucoma (raised pressure in your eyes)
• diabetes or epilepsy
• a caesarean section or any other operation on your womb.

If you have not told your doctor, nurse or other healthcare provider about any of the above, tell him/her before you are given CARBOPROST-REACH.

Do not use this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

If you are not sure whether you should be using this medicine, talk to your doctor, nurse or other healthcare provider.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and CARBOPROST-REACH may interfere with each other. These include:

• treatments that strengthen contraction of the womb, including oxytocin and ergometrine.

These medicines may be affected by CARBOPROST-REACH or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect CARBOPROST-REACH.

4. How do I use CARBOPROST-REACH?

CARBOPROST-REACH should be used by medically trained staff in hospitals and clinics with specialised obstetric units where 24 hour medical care is available.

How much is given

The dose of CARBOPROST-REACH will be determined by your doctor for your individual requirements.

The first dose is usually 1 mL of solution (250 µg of carboprost). Your doctor may give you more doses of 1 mL if you need them.

You should not have doses more often than once every 15 minutes. Usually you would have them less often, about once in one and-a-half hours.

You should not be given more than 8 doses (2 mg of carboprost) altogether.

How it is given

CARBOPROST-REACH is given by injection deep into a muscle. It must never be given by injection into a vein.

When it is given

Your doctor will determine you long you should be treated. Your doctor will make sure that this medicine is used in the right way and at the right time.

If you are given too much (overdose)

Your doctor has information on how to recognise and treat an overdose.

If you are given too much CARBOPROST-REACH and you are nauseous, vomiting or experience very bad diarrhoea, your doctor may delay the next injection of CARBOPROST-REACH or may not give you any more doses.

If you think you have been given too much CARBOPROST-REACH, talk to your doctor, nurse or other healthcare provider immediately.

If you continue to bleed heavily after being given CARBOPROST-REACH, you may be given other medicines to help control the bleeding. Your doctor, nurse or other healthcare provider will be watching you closely to help them decide whether CARBOPROST-REACH is working for you.

5. What should I know while using CARBOPROST-REACH?

Things you should do

Tell your doctor, nurse or other healthcare provider if you intend to breastfeed your baby.

• It is not known if CARBOPROST-REACH is excreted in human breast milk.
• You should wait for at least 6 hours after receiving your last dose of CARBOPROST-REACH before breastfeeding your baby.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how CARBOPROST-REACH affects you.

Do not drive, use any tools or operate machinery soon after receiving CARBOPROST-REACH as it may affect your ability to do so safely. CARBOPROST-REACH may make you lose consciousness, feel dizzy or drowsy.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Tell your doctor, nurse or other healthcare provider if you notice any of the following and they worry you:

• nausea, vomiting or retching
• dizziness, unsteadiness when walking or spinning sensation
• ringing in the ears
• blurred vision or eye pain
• abnormal taste
• excessive thirst
• dry throat or dry mouth
• hiccups
• coughing
• nose bleeds
• flushing
• hot flushes
• tingling or pins and needles in the hands or feet, sudden numbness or weakness in the legs or arms
• cramps or muscle spasms
• tenderness of the breasts
• general muscle pain
• stomach or abdominal pain
• back pain, pelvic pain
• feeling of tiredness or lack of energy
• pain or burning during urination
• infection affecting the nose sinuses and throat
• irregular sleep patterns or general feeling of sleepiness or drowsiness
• anxiety
• nervousness
• local reaction around the injection site such as redness, itchiness, tenderness, pain or discomfort, warmth, burning, stinging or swelling.

Tell your doctor, nurse or other healthcare provider immediately if you get any of the following side effects:

• sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body
• coughing or vomiting up blood, difficulty breathing as a result of fluid retention in the lungs
• chest pain or discomfort
• breathing difficulties such as rapid breathing or wheezing
• high blood pressure
• abdominal pain, vaginal bleeding, rapid pulse rate, chest pains as a result of tearing, wound or cut in the muscles of the womb
• high fever, chills or shivering, headache, rapid heart rate, confusion, rapid breathing as a result of septic shock
• continued heavy bleeding after your child has been delivered as a result of retained placenta or membranes
• temporary loss of consciousness caused by a fall in blood pressure
• swelling of the throat, choking sensation
• muscle contractions affecting your posture and positioning of the head
• uncontrolled abnormal contraction or twitch of the eyelid
• abnormal physical weakness
• diarrhoea, weight loss, rapid heart rate, excessive or increased levels of sweating or perspiration and very high body temperature from a rare but severe form of hyperthyroidism.

These are very serious side effects. You may need urgent medical attention.

Other side effects not listed above may occur in some patients. Tell your doctor, nurse or other healthcare provider if you notice anything that is making you feel unwell.

Do not be alarmed by this list of possible side effects.

You or your child may not experience any of them.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What CARBOPROST-REACH contains

Do not take this medicine if you are allergic to any of these ingredients.

What CARBOPROST-REACH looks like

CARBOPROST-REACH is a clear, colourless solution available in glass ampoules containing 1mL of solution.

CARBOPROST-REACH is supplied in a pack of 10 (AUST R 394092).

Who distributes CARBOPROST-REACH

Reach Pharmaceuticals
Ground Floor, Corporate One,
84 Hotham Street, Preston VIC 3072

This leaflet was prepared in June 2023.

Published by MIMS August 2023

1 Name of Medicine

Carboprost (as trometamol).

2 Qualitative and Quantitative Composition

Each 1 mL contains 250 microgram carboprost or 332 microgram carboprost (as trometamol).

Excipients with known effect.

3 Pharmaceutical Form

Solution for injection.
Carboprost-Reach is a clear colourless solution.

4 Clinical Particulars

4.1 Therapeutic Indications

Carboprost-Reach is indicated for the treatment of postpartum haemorrhage due to uterine atony which has not responded to conventional methods of management.

4.2 Dose and Method of Administration

An initial dose of 250 microgram (1 mL) is to be given by deep intramuscular injection. If necessary, further doses of 250 microgram may be administered at intervals of approximately 1.5 hours. In severe cases the interval between doses may be reduced at the discretion of the attending physician, but it should not be less than 15 minutes. The total dose of Carboprost-Reach should not exceed 2 mg (8 doses).
Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration.
Product is for single use in one patient only. Discard any residue.

4.3 Contraindications

1. Hypersensitivity to carboprost trometamol or any of the excipients of Carboprost-Reach (see Section 6.1 List of Excipients).
2. Acute pelvic inflammatory disease.
3. Patients with active cardiac, pulmonary, renal or hepatic disease.
4. Carboprost-Reach is contraindicated in pregnancy.

4.4 Special Warnings and Precautions for Use

Carboprost-Reach should be used by appropriately trained personnel in hospitals and clinics with specialised obstetric units.
Carboprost-Reach, as with other potent oxytocic agents, should be used only with strict adherence to recommended dosages.
This preparation should not be used for the induction of labour.
Carboprost-Reach must not be given intravenously.
Very rare cases of cardiovascular collapse have been reported following the use of prostaglandins. This should always be considered when using Carboprost-Reach.
Carboprost-Reach contains benzyl alcohol which has been reported to be associated with a fatal "gasping syndrome" in premature infants. The preservative benzyl alcohol has been associated with serious adverse events, including the "gasping syndrome", and death in paediatric patients. The minimum amount of benzyl alcohol at which toxicity may occur is not known. The risk of benzyl alcohol toxicity depends on the quantity administered and the liver and kidneys' capacity to detoxify the chemical. Premature and low-birth weight infants may be more likely to develop toxicity. High volumes should be used with caution and only if necessary, especially in subjects with liver or kidney impairment because of the risk of accumulation and toxicity (metabolic acidosis).
Carboprost-Reach should be used with caution in patients with a history of glaucoma or raised intra-ocular pressure, asthma, hypotension or hypertension, cardiovascular, renal or hepatic disease, anaemia, jaundice, diabetes or epilepsy.
During the clinical trials with carboprost, 5/115 (4%) patients had an increase in blood pressure reported as a side effect. The degree of hypertension was moderate. The cases reported did not require specific therapy for the elevated blood pressure.
Since prostaglandins may potentiate the effect of oxytocin, it is recommended that the use of these drugs simultaneously or in sequence should be carefully monitored.
Animal studies lasting several weeks at high doses have shown that prostaglandins of the E and F series can induce proliferation of bone. Such effects have also been noted in newborn infants who have received prostaglandin E1 during prolonged treatment. There is no evidence that short term administration of carboprost can cause similar bone effects.
As with any oxytocic agent, Carboprost-Reach should be used with caution in patients with previously compromised (scarred) uteri.

Use in patients with chorioamnionitis.

Use in patients with pre-existing cardio-pulmonary problems.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Carboprost-Reach may augment the activity of other oxytocic agents. Concomitant use with other oxytocic agents is not recommended.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.
There have been reports of undesirable effects such as syncope, dizziness and somnolence which could impair the ability to drive or use machines. Therefore patients should refrain from driving until they know that Carboprost-Reach does not affect their ability to drive or use machines.

4.8 Adverse Effects (Undesirable Effects)

The adverse effects of Carboprost-Reach are generally transient and reversible on cessation of therapy.

Clinical trials.

Post-marketing experience.

Immune system disorders.

Endocrine disorders.

Psychiatric disorders.

Nervous system disorders.

Cardiac disorders.

Respiratory, thoracic and mediastinal disorders.

Gastrointestinal disorders.

Skin and subcutaneous tissue disorders.

Musculoskeletal and connective tissue disorders.

General disorders and administration site conditions.

Reporting suspected adverse effects.

Treatment of overdosage must be symptomatic at this time, as clinical studies with prostaglandin antagonists have not progressed to the point where recommendations may be made. If evidence of adverse effects appears, the frequency of administration of Carboprost-Reach should be decreased or administration discontinued.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Five women who had spontaneous vaginal deliveries (at term) were treated immediately postpartum with a single intramuscular injection of 250 microgram carboprost. Peripheral blood samples were collected at several times during the four hours following treatment. The highest concentration was observed at 15 minutes in two patients (3009 and 2916 picogram/mL), at 30 minutes in two patients (3097 and 2792 picogram/mL) and at 60 minutes in one patient (2718 picogram/mL).

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

Teratogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Trometamol, sodium chloride, sodium hydroxide or hydrochloric acid (for pH adjustment), water for injection, benzyl alcohol (added as preservative).

6.2 Incompatibilities

No data available.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store at 2°C to 8°C. Do not freeze. Protect from light.

6.5 Nature and Contents of Container

Vial.

6.6 Special Precautions for Disposal

Any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Carboprost-Reach injection is a colourless, sterile aqueous solution for intramuscular administration. It contains carboprost trometamol equivalent to 250 microgram carboprost in 2 mL vials.
Carboprost trometamol is the trometamol salt of the (15S)-15 methyl analogue of naturally occurring prostaglandin F2α (CAS 58551-69-2). The chemical name is (15S)-9α, 11α, 15-trihydroxy-15-methyl- prosta-cis-5, trans-13-dienoic acid trometamol salt.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription only medicine.

Summary Table of Changes