Enwylma 120mg solution for injection

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
• Your doctor will give you a patient reminder card, which contains important safety information you need to be aware of before and during your treatment with Enwylma.

1. What Enwylma is and what it is used for
2. What you need to know before you use Enwylma
3. How to use Enwylma
4. Possible side effects
5. How to store Enwylma
6. Contents of the pack and other information

• if you are allergic to denosumab or any of the other ingredients of this medicine (listed in section 6).

Your healthcare professional will not administer Enwylma to you if you have a very low level of calcium in your blood which has not been treated.

Your healthcare professional will not administer Enwylma to you if you have unhealed wounds from dental or oral surgery.

Talk to your doctor before using Enwylma.

Calcium and vitamin D supplementation

You should take calcium and vitamin D supplements while being treated with Enwylma unless your blood calcium is high. Your doctor will discuss this with you. If the level of calcium in your blood is low, your doctor may decide to give you calcium supplements before you start treatment with Enwylma.

Low calcium levels in the blood

Please tell your doctor immediately if you have spasms, twitches, or cramps in your muscles, and/or numbness or tingling in your fingers, toes or around your mouth and/or seizures, confusion or loss of consciousness while being treated with Enwylma. You may have low levels of calcium in your blood.

Renal impairment

Tell your doctor if you have or have had severe kidney problems, kidney failure or have needed dialysis, which may increase your risk of getting low blood calcium, especially if you do not take calcium supplements.

Problems with your mouth, teeth or jaw

A side effect called osteonecrosis of the jaw (bone damage in the jaw) has been reported commonly (may affect up to 1 in 10 people) in patients receiving Enwylma injections for cancer-related conditions. Osteonecrosis of the jaw can also occur after stopping treatment.

It is important to try to prevent osteonecrosis of the jaw developing as it may be a painful condition that can be difficult to treat. In order to reduce the risk of developing osteonecrosis of the jaw, there are some precautions you should take:

• Before receiving treatment, tell your doctor/nurse (healthcare professional) if you have any problems with your mouth or teeth. Your doctor should delay the start of your treatment if you have unhealed wounds in your mouth from dental procedures or oral surgery. Your doctor may recommend a dental examination before you start treatment with Enwylma.
• While being treated, you should maintain good oral hygiene and receive routine dental check-ups. If you wear dentures you should make sure these fit properly.
• If you are under dental treatment or will undergo dental surgery (e.g. tooth extractions), inform your doctor about your dental treatment and tell your dentist that you are being treated with Enwylma.
• Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, non-healing of sores or discharge, as these could be signs of osteonecrosis of the jaw.

Patients undergoing chemotherapy and/or radiotherapy, taking steroids or anti-angiogenic medicines (used to treat cancer), undergoing dental surgery, who do not receive routine dental care, have gum disease or who are smokers, may have a higher risk of developing osteonecrosis of the jaw.

Unusual thigh bone fractures

Some people have developed unusual fractures in their thigh bone while being treated with Enwylma. Contact your doctor if you experience new or unusual pain in your hip, groin, or thigh.

High calcium levels in the blood after stopping treatment with Enwylma

Some patients with giant cell tumour of the bone have developed high calcium levels in the blood weeks to months after stopping treatment. Your doctor will monitor you for signs and symptoms of high levels of calcium, after you stop receiving Enwylma.

Enwylma is not recommended for children and adolescents under 18 years of age except for adolescents with giant cell tumour of the bone whose bones have stopped growing. The use of Enwylma has not been studied in children and adolescents with other cancers that have spread to bone.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription. It is especially important that you tell your doctor if you are being treated with

• another medicine containing denosumab
• a bisphosphonate

You should not take Enwylma together with other medicines containing denosumab or bisphosphonates.

Enwylma has not been tested in pregnant women. It is important to tell your doctor if you are pregnant, think you may be pregnant, or plan to get pregnant. Enwylma is not recommended for use if you are pregnant. Women of child-bearing potential should use effective methods of contraception while being treated with Enwylma and for at least 5 months after stopping treatment with Enwylma.

If you become pregnant during treatment with Enwylma or less than 5 months after stopping treatment with Enwylma, please inform your doctor.

It is not known whether denosumab is excreted in breast milk. It is important to tell your doctor if you are breast-feeding or plan to do so. Your doctor will then help you decide whether to stop breast-feeding, or whether to stop taking denosumab, considering the benefit of breast-feeding to the baby and the benefit of denosumab to the mother.

If you are breast-feeding during treatment with Enwylma, please inform your doctor.

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

Enwylma has no or negligible influence on the ability to drive and use machines.

This medicine contains 78 mg of sorbitol in each vial.

This medicine contains less than 1 mmol sodium (23 mg) per 120 mg, that is to say essentially ‘sodium-free’.

This medicine contains 0.17 mg of polysorbate 20 (E 432) in vial which is equivalent to 0.1 mg/mL. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/ yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is denosumab. Each vial contains 120 mg of denosumab in 1.7 mL of solution (corresponding to 70 mg/mL).
• The other ingredients are acetic acid (glacial), sodium hydroxide, sorbitol (E420), polysorbate 20 and water for injections.

Enwylma is a solution for injection (injection).

Enwylma is a clear, colourless to yellowish solution. It may contain trace amounts of clear to white particles.

Each pack contains one, three or four single use vials.

Not all pack sizes may be marketed.