SUMMARY CMI

Prolutex 25 mg Solution for Injection

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 being given Prolutex?

Prolutex contains the active ingredient progesterone, a naturally-occurring female sex hormone. Prolutex is for women who need extra progesterone while undergoing treatment in an Assisted Reproductive Technology (ART) program who are unable to use or tolerate vaginal preparations or where there is a need or preference to use an injectable form of progesterone.

For more information, see Section 1. Why am I being given Prolutex? in the full CMI.

2. What should I know before I am given Prolutex?

Do not use if you have ever had an allergic reaction to progesterone 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 am given Prolutex? in the full CMI.

3. What if I am taking other medicines?

Some medicines, including medicines obtained without a prescription and herbal medicines, may interfere with Prolutex 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 Prolutex?

Prolutex can be given either under your skin (subcutaneous injection) or into a muscle (intramuscular injection). Intramuscular injections must only be given by a doctor. You will be able to administer 25 mg of Prolutex subcutaneously after suitable advice and training by your doctor or healthcare professional.

The usual dose is a once daily injection of 25 mg for up to 12 weeks of confirmed pregnancy (i.e. 10 weeks of treatment).

More instructions can be found in Section 4. How is Prolutex given? in the full CMI.

5. What should I know while being given Prolutex?

For more information, see Section 5. What should I know while being given Prolutex? in the full CMI.

6. Are there any side effects?

More common side effects of Prolutex include pain, redness, itching, irritation or swelling at the injection site, headache, bloated stomach, stomach pain, constipation, being sick and feeling sick, breast tenderness and/or pain, hardening of area around injection site, bruising around injection site, fatigue (excessive tiredness, exhaustion, lethargy).

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

Prolutex 25 mg Solution for Injection

Active ingredient(s): progesterone

Consumer Medicine Information (CMI)

This leaflet provides important information about using Prolutex. 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 Prolutex.

Where to find information in this leaflet:

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

1. Why am I being given Prolutex?

Prolutex contains the active ingredient progesterone. Progesterone is a naturally occurring female sex hormone.

Prolutex is for women who need extra progesterone while undergoing treatment in an Assisted Reproductive Technology (ART) program who are unable to use or tolerate vaginal preparations.

The medicine works on the lining of the womb and helps you to become pregnant and to stay pregnant.

Your doctor may have prescribed Prolutex for another reason. Ask your doctor if you have any questions about why Prolutex has been prescribed for you.

Prolutex is not addictive.

2. What should I know before I am given Prolutex?

Warnings

Do not use Prolutex if:

• you are allergic to progesterone, or any of the ingredients listed at the end of this leaflet.
• If you are suffering from vaginal bleeding (other than normal periods) that has not been evaluated by your doctor
• If you have had a miscarriage and your doctor suspects some tissue is still in the womb
• If you have had a pregnancy outside of the womb (ectopic pregnancy)
• If you currently have or have had severe liver problems
• If you have known or suspected breast cancer or cancer of the reproductive tract
• If you have or have had blood clots in the legs, lungs, eyes or elsewhere in the body
• If you have porphyria disorders (a group of inherited or acquired disorders of certain enzymes)
• If during pregnancy you have suffered from jaundice (yellowing of eyes and skin due to liver problems) severe itching and/or blisters on the skin
• If you are under 18 years of age.

Tell your doctor immediately, or go to Accident and Emergency at your nearest hospital if you notice any of the following:

• Heart attack (pains in the chest, or back pain and/or deep aching and throbbing in one or both arms, a sudden shortness of breath, sweating, dizziness, light-headedness, nausea, palpitations)
• Stroke (severe headache or vomiting, dizziness, faintness, or changes in vision or speech, weakness or numbness of an arm or leg.)
• Blood clots in the eyes or anywhere in the body (pain in your eyes or pain and swelling in your ankles, feet and hands)
• Worsening of depression
• Severe headaches, changes in vision.

These are very serious side effects; you may need urgent medical attention or hospitalisation.

Check with your doctor if you:

Tell your doctor or pharmacist if you have allergies to:

• any other medicines
• any other substances, such as foods, preservatives or dyes

Tell your doctor if you have had or have any of the following before using Prolutex:

• Liver problems (mild or moderate)
• Epilepsy
• Migraine
• Asthma
• Heart or kidney problems
• Diabetes
• Depression

If any of the above applies to you, your doctor will monitor you carefully during treatment.

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine.

• Prolutex can be used during the first three months of pregnancy.
• This medicine should not be used during breast-feeding.

Children and adolescents

The product is not to be used by children or adolescents.

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 Prolutex may interfere with each other. These include:

• Carbamazepine (used to treat seizures/fits)
• Rifampicin (an antibiotic)
• Griseofulvin (an antifungal medicine)
• Phenytoin and phenobarbital (used to treat epilepsy)
• St. John's Wort-containing herbal products
• Ciclosporin (a medicine for some types of inflammation and after organ transplants)
• Diabetic medicines
• Ketoconazole (an antifungal medicines)

Do not administer Prolutex at the same time as any other injectable medicine.

Your doctor and pharmacist may have more information on medicines to be careful with or avoid while having Prolutex.

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

4. How do I use Prolutex?

How much is given

The usual dose is an injection of 25 mg once-daily. As per template, Follow instructions provided...

How Prolutex is given

Always use Prolutex exactly as your doctor has told you. Remember Prolutex should only be used under the supervision of a doctor experienced in treating fertility problems.

A doctor must perform all intramuscular (IM) injections of Prolutex.

However, you will be able to administer 25 mg of Prolutex subcutaneously yourself after suitable advice and training by your doctor or healthcare professional.

How long Prolutex is given for

Prolutex should normally be administered once-daily until 12 weeks of confirmed pregnancy (i.e. 10 weeks of treatment).

Subcutaneous Injection

Before you inject Prolutex you will receive the following training and advice:

• Practice giving subcutaneous injections
• Where to inject your medicine
• How to prepare your solution for injection
• How to administer your medicine.

Please read all instructions below on preparation and administration of Prolutex.

The steps for self-administration are:

1. Preparing your injection
2. Checking pack
3. Preparing the vial and syringe
4. Filling the syringe
5. Changing the injecting needle
6. Removing air bubbles
7. Injection by subcutaneous administration
8. Disposal of used items.

These steps are explained in full below.

IMPORTANT: each vial should only be used once. The solutions should be used immediately after opening the vial. It should not be stored in the syringe.

Any remaining solution must be discarded.

1. Preparing your injection

It is important to keep everything as clean as possible, so start by washing your hands thoroughly and drying on a clean towel. Choose a clean area to prepare your medicine:

• One vial containing Prolutex solution for injection

The following are not supplied with your medicine. Your doctor or pharmacist will supply these items.

• One syringe
• One large needle (typically 21G green needle; for intramuscular administration)
• One small fine needle (typically 27G grey needle; for subcutaneous injection)
• Two alcohol wipes
• A sharps container (for safe disposal of needles, vials etc.)

2. Checking pack

• The Prolutex vial syringe and needles all have protective covers.
• Check that all the covers are on firmly and if they are not on properly or are damaged, do not use them
• Make sure that the expiry date is still valid on the vial of Prolutex. Do not use the products if outside the expiry date

3. Preparing the vial and syringe

• Remove the plastic cap from the top of a Prolutex vial by gently pushing it upwards.
• Wipe the rubber top with an alcohol wipe and allow to dry
• Unpack the syringe, hold the syringe
• Take the packaging off the large 21G green needle, but keep the needle cover on
• Hold the syringe in your hand, attach the large 21G green needle to the syringe, then remove the needle cover

4. Filling the syringe

• Push the large 21G green needle through the rubber middle of the Prolutex vial top
• With the needle still inserted, turn the vial upside down. The needle should support the vial unaided
• Make sure the large needle tip is underneath the level of the liquid
• Gently pull the plunger to draw all the mixture into the syringe
• Pull the large needle out of the vial.

5. Changing the injecting needle

This step is only required if you are doing a subcutaneous administration; if your doctor is performing an intramuscular injection, they will move on to set the dose and administer the injection.

• Put the needle cover on the large 21G green needle and then gently take the large needle off the syringe
• Remove the smaller 27G grey injecting needle, from its package, keeping the needle cover on
• Attach the small 27G grey needle onto the syringe then remove the needle cover.

6. Removing air bubbles

• Holding the syringe straight up with the small 27G grey needle pointing to the ceiling, draw back slightly on the plunger and tap the syringe so that any air bubbles rise to the top.
• Slowly press the plunger until all the air is out of the syringe and at least one drop of solution comes out of the tip of the small 27G grey needle

7. Injection by subcutaneous administration

• Your doctor or healthcare professional will have already shown you where to inject Prolutex (e.g. tummy or front of thigh)
• Open the alcohol wipe and carefully clean the area of skin to be injected, and allow it to dry
• Hold the syringe in one hand. Use the other hand to gently pinch the skin in the injection site area between your thumb and index finger

• Using a dart-like motion insert the fine grade small 27G grey needle into the skin so the skin and needle form a right angle.
• Insert the small 27G grey needle all the way into the skin. Do not inject directly into a vein
• Inject the solution by pushing gently on the plunger in a slow and steady motion until all the solution is injected beneath the skin. Inject all of the prescribed solution
• Release the skin and pull the needle straight out
• Wipe the skin at the injection site with an alcohol swab using a circular motion.

8. Disposal of used items

• Once you have finished your injection, put all needles, empty vials and syringes into a sharps container.
• Any unused solution must also be thrown away.

Injection by intramuscular administration should only be given by a doctor or healthcare professional

For all intramuscular injections, your doctor or another healthcare professional will perform the injection.

The Prolutex injection will be given into the side of the thigh or bottom. Your doctor or healthcare professional will clean the area of skin to be injected using an alcohol wipe, and allow it to dry. Using a dart-like motion they will insert the large needle into the muscle. They will inject the solution by pushing gently on the plunger in a slow and steady motion until all the solution is injected into the muscle. They will pull the needle straight out and wipe the skin at the injection site with an alcohol wipe.

If you are given too much Prolutex

Tell your doctor or pharmacist. The symptoms of an overdose include drowsiness.

If you use too much Prolutex by SC injection

If you think that you have used too much Prolutex, you may need urgent medical attention.

• You should immediately phone the Poisons Information Centre (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while being given Prolutex?

Things you should do

If you forget to use Prolutex, take the dose as soon as you remember and then carry on as before. Do not take a double dose to make up for a forgotten dose. Tell your doctor what you have done.

Things you should not do

Do not stop using Prolutex without speaking to your doctor or pharmacists first. Abrupt discontinuation of Prolutex may cause increased anxiety, moodiness, and increase your risk of having seizures (fits).

Do not use Prolutex after the expiry date which is stated on the label after Exp: The expiry date refers to the last day of that month.

Do not use Prolutex if you notice particles in the solution or if the solution is not clear.

Driving or using machines

Be careful driving or operating machinery until you know how Prolutex affects you. As with many other medicines, Prolutex may cause dizziness or drowsiness in some people.

Drinking alcohol

You should not drink alcohol while you are on Prolutex, as it may make any dizziness or drowsiness worse.

Looking after your medicine

Keep out of the sight and reach of children.

Store below 25°C. Do not refrigerate or freeze.

Store in the original package to protect from light.

Getting rid of any unwanted medicine

Medicines should not be disposed of via wastewater or household waste. If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

6. Are there any side effects?

Like all medicines, Prolutex can cause side effects, although not everybody gets them. Tell your doctor, nurse or pharmacist as soon as possible if you do not feel well while you are taking Prolutex.

Ask your doctor or pharmacist to answer any questions you may have.

Less serious side effects

Serious side effects

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 Prolutex contains

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

What Prolutex looks like

Prolutex is a clear, colourless solution in a clear glass vial. Each vial is used only once and any leftover material is discarded.

It is approved in packs of 7 vials.

Australian Registration Numbers:

25 mg: 456005

Who distributes Prolutex

Boucher & Muir Pty Ltd
Advanz Pharma Pty Ltd
Level 9, 76 Berry Street,
North Sydney 2060
NSW
Australia

This leaflet was revised in December 2024.

Published by MIMS February 2025

1 Name of Medicine

Progesterone.

2 Qualitative and Quantitative Composition

Each vial (1.112 mL) contains 25 mg of progesterone (theoretical concentration 22.48 mg/mL).
For a full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Progesterone solution for injection is a clear colourless solution.

4 Clinical Particulars

4.1 Therapeutic Indications

Prolutex is indicated in adults for luteal support as part of an Assisted Reproductive Technology (ART) treatment program in women who are unable to use or tolerate vaginal preparations, or where there is a need or preference to use an injectable form of progesterone.

4.2 Dose and Method of Administration

The solution should not be administered if it contains particles or is discoloured.

Dose.

Adults.

Special populations.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Method of administration.

Intramuscular administration.

Subcutaneous administration.

4.3 Contraindications

Prolutex should not be used in individuals with any of the following conditions:
Hypersensitivity to progesterone or to any of the excipients.
Undiagnosed vaginal bleeding.
Known missed abortion or ectopic pregnancy.
Severe hepatic dysfunction or disease.
Known or suspected breast or genital tract cancer.
Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events.
Porphyria.
A history of idiopathic jaundice, severe pruritus or pemphigoid gestationis during pregnancy.

4.4 Special Warnings and Precautions for Use

Prolutex should be discontinued if any of the following conditions are suspected: myocardial infarction, cerebrovascular disorders, arterial or venous thromboembolism, thrombophlebitis, or retinal thrombosis.
Patients with a history of depression need to be closely observed. Consider discontinuation if symptoms worsen.
Because progesterone may cause some degree of fluid retention, conditions that might be influenced by this factor (e.g. epilepsy, migraine, asthma, cardiac or renal dysfunction) require careful observation.
A decrease in insulin sensitivity and thereby in glucose tolerance has been observed in a small number of patients on oestrogen-progestogen combination drugs. The mechanism of this decrease is not known. For this reason, diabetic patients should be carefully observed while receiving progesterone therapy (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Sex steroid use may also increase the risk of retinal vascular lesions. To prevent these latter complications, caution is to be taken in users > 35 years, in smokers, and in those with risk factors for atherosclerosis. Use should be terminated in case of transient ischemic events, appearance of sudden severe headaches, or vision impairments related to papillary oedema or retinal haemorrhage.
Abrupt discontinuation of progesterone dosing may cause increased anxiety, moodiness, and increased sensibility to seizures.
Before starting treatment with Prolutex, the patient and her partner should be assessed by a doctor for causes of infertility or pregnancy complications.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Drugs known to induce the hepatic cytochrome P450 3A4 system (e.g. rifampicin, carbamazepine, griseofulvin, phenobarbital, phenytoin or St. John's wort (Hypericum perforatum)-containing herbal products) may increase the elimination rate and thereby decrease the bioavailability of progesterone.
In contrast, ketoconazole and other inhibitors of cytochrome P450 3A4 may decrease elimination rate and thereby increase the bioavailability of progesterone.
Since progesterone can influence diabetic control an adjustment in antidiabetic dosage could be required (see Section 4.4 Special Warnings and Precautions for Use).
Progestogens may inhibit ciclosporin metabolism leading to increased plasma ciclosporin concentrations and a risk of toxicity.
The effect of concomitant injectable products on the exposure of progesterone from Prolutex has not been assessed. Concomitant use with other drugs is not recommended.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

Prolutex has minor or moderate influence on the ability to drive and use machines. Progesterone may cause drowsiness and/or dizziness; therefore, caution is advised in drivers and those operating machinery.

4.8 Adverse Effects (Undesirable Effects)

The most frequently reported adverse drug reactions during treatment with Prolutex during clinical trials are administration site reactions, and breast and vulvovaginal disorders.
Table 1 displays the main adverse drug reactions in women treated with Prolutex in the pivotal clinical trial 07EU/Prg06; in this study, 338 women received Prolutex 25 mg daily for luteal phase support, treatment and emergent adverse events have been occurred in ≥ 5% of women.
Data is expressed by system organ class (SOC) and frequency.

Class effects.

Reporting suspected adverse effects.

4.9 Overdose

High doses of progesterone may cause drowsiness.
Treatment of overdose consists of discontinuation of Prolutex together with initiation of appropriate symptomatic and supportive care.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Sex hormones and modulators of the genital system; progestogens; Pregnen (4) derivatives, ATC code: G03DA04.

Mechanism of action.

Clinical trials.

Study 1.

Study 2.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Carcinogenicity.

Genotoxicity.

Reproductive and developmental toxicology.

Fertility and reproduction.

6 Pharmaceutical Particulars

6.1 List of Excipients

Prolutex contains hydroxypropyl betadex and water for injections.

6.2 Incompatibilities

Prolutex should be administered without further dilution. Compatibility with other solutions has not been determined.

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 below 25°C. Do not refrigerate or freeze. Protect from light.

6.5 Nature and Contents of Container

Clear, colourless solution enclosed in colourless type I glass vial fitted with a bromobutyl rubber stopper, and an aluminium seal and 'flip-off' cap. Each pack contains 7 vials.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.