Evfraxy

Do not take it if

From the package leaflet in EMA’s product information, p. 28.

How to take it

These directions are for this exact strength and form. Another one is different.

• The recommended dose is one pre-filled syringe of 60 mg administered once every 6 months, as a single injection under the skin (subcutaneous). The best places to inject are the top of your thighs and the abdomen. Your carer can also use the outer area of your upper arm. Please consult your doctor on the date for a potential next injection. Each pack of Evfraxy contains a reminder card, that can be removed from the carton and used to keep a record of the next injection date.
• You should also take calcium and vitamin D supplements while being on treatment with Evfraxy. Your doctor will discuss this with you.
• Your doctor may decide that it is best for you or a carer to inject Evfraxy. Your doctor or healthcare provider will show you or your carer how to use Evfraxy. For instructions on how to inject Evfraxy, please read the section at the end of this leaflet.
• Do not shake.
• If you forget to use Evfraxy If a dose of Evfraxy is missed, the injection should be administered as soon as possible. Thereafter, injections should be scheduled every 6 months from the date of the last injection.
• If you stop using Evfraxy To get the most benefit from your treatment in reducing the risk of fractures, it is important to use Evfraxy for as long as your doctor prescribes it for you. Do not stop your treatment without contacting your doctor.

From the package leaflet in EMA’s product information, p. 30.

Warnings and precautions

From the package leaflet in EMA’s product information, p. 28–29.

Pregnancy and breastfeeding

From the package leaflet in EMA’s product information, p. 29.

Other medicines

From the package leaflet in EMA’s product information, p. 29.

Driving and using machines

• Evfraxy has no or negligible influence on the ability to drive and use machines.
• Evfraxy contains sorbitol This medicine contains 47 mg sorbitol in each mL of solution.
• Evfraxy contains sodium This medicine contains less than 1 mmol sodium (23 mg) per 60 mg, that is to say essentially ‘sodium- free’.
• Evfraxy contains Polysorbate 20 This medicine contains 0.1 mg of polysorbate 20 in each 60 mg/mL pre-filled syringe which is equivalent to 0.1 mg/mL. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

From the package leaflet in EMA’s product information, p. 29.

Side effects

• Like all medicines, this medicine can cause side effects, although not everybody gets them.
• Uncommonly, patients receiving Evfraxy may develop skin infections (predominantly cellulitis).
• Please tell your doctor immediately if you develop any of these symptoms while being on treatment with Evfraxy: swollen, red area of skin, most commonly in the lower leg, that feels hot and tender, and possibly with symptoms of fever.
• Rarely, patients receiving Evfraxy may develop pain in the mouth and/or jaw, swelling or non-healing of sores in the mouth or jaw, discharge, numbness or a feeling of heaviness in the jaw, or loosening of a tooth. These could be signs of bone damage in the jaw (osteonecrosis). Tell your doctor and dentist immediately if you experience such symptoms while being treated with Evfraxy or after stopping treatment.
• Rarely, patients receiving Evfraxy may have low calcium levels in the blood (hypocalcaemia) ;
• severely low blood calcium levels may lead to hospitalisation and may even be life-threatening.
• Symptoms include 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. If any of these apply to you, tell your doctor immediately. Low calcium in the blood may also lead to a change in heart rhythm called QT prolongation which is seen by electrocardiogram (ECG).
• Rarely unusual fractures of the thigh bone may occur in patients receiving Evfraxy. Contact your doctor if you experience new or unusual pain in your hip, groin or thigh as this may be an early indication of a possible fracture of the thigh bone.
• Rarely, allergic reactions may occur in patients receiving Evfraxy. Symptoms include swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin, wheezing or difficulty breathing. Please tell your doctor if you develop any of these symptoms while being treated with Evfraxy.
• Very common side effects (may affect more than 1 in 10 people):
• bone, joint, and/or muscle pain which is sometimes severe,
• arm or leg pain (pain in extremity).
• Common side effects (may affect up to 1 in 10 people):
• painful urination, frequent urination, blood in the urine, inability to hold your urine,
• upper respiratory tract infection,
• pain, tingling or numbness that moves down your leg (sciatica),
• constipation,
• abdominal discomfort,
• rash,
• skin condition with itching, redness and/or dryness (eczema),
• hair loss (alopecia).
• Uncommon side effects (may affect up to 1 in 100 people):
• fever, vomiting and abdominal pain or discomfort (diverticulitis),
• ear infection,
• rash that may occur on the skin or sores in the mouth (lichenoid drug eruptions).
• Very rare side effects (may affect up to 1 in 10,000 people):
• allergic reaction that can damage blood vessels mainly in the skin (e.g. purple or brownish-red spots, hives or skin sores) (hypersensitivity vasculitis).
• Not known (frequency cannot be estimated from the available data):
• talk to your doctor if you have ear pain, discharge from the ear and/or an ear infection. These could be signs of bone damage in the ear.
• Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

From the package leaflet in EMA’s product information, p. 30–31.

How to store it

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.
• Store in a refrigerator (2°C – 8°C).
• Do not freeze.
• Keep the container in the outer carton in order to protect from light.
• Your pre-filled syringe may be left outside the refrigerator to reach room temperature (up to 25°C)
• before injection. This will make the injection more comfortable. Once your syringe has been left to reach room temperature (up to 25°C), it must be used within 30 days.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

From the package leaflet in EMA’s product information, p. 31.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

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Details

Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician

Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).

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Same active substance

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