Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
EVENITY 105 mg solution for injection in pre-filled pen
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Romosozumab may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Draft
What EVENITY is EVENITY contains the active substance romosozumab, a medicine that helps to make the bones stronger, and reduce the risk of broken bones. What EVENITY is used for EVENITY is used to treat severe osteoporosis in women after the menopause who are at high risk of broken bone (fracture). Osteoporosis is a disease that causes your bones to become thin and fragile. Many patients with osteoporosis have no symptoms, but they may be at increased risk of fractures. How EVENITY works EVENITY is a monoclonal antibody. A monoclonal antibody is a type of protein that has been designed to recognize and attach to specific proteins in the body. EVENITY attaches to a protein called sclerostin. By attaching to and blocking the activity of sclerostin, EVENITY: • helps to form new bone, and • slows down the loss of existing bone. This makes the bones stronger, and lowers the risk of fractures. 2.
What you need to know before you take it
e EVENITY
Do not use EVENITY if • you are allergic to romosozumab or any of the other ingredients of this medicine (listed in section 6); • you have low levels of calcium in the blood (hypocalcaemia). Your doctor will be able to tell you if your levels are too low; 1
•
you have a history of heart attack or stroke.
Do not use EVENITY if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before using EVENITY. Warnings and precautions Talk to your doctor or pharmacist and discuss your medical history before using EVENITY. Heart attack and stroke Heart attack and stroke have been reported in people receiving EVENITY. Seek medical attention straight away if you get: • chest pain, shortness of breath; • headache, numbness, or weakness in your face, arms, or legs, difficulty talking, changes in vision, loss of balance. Your doctor will carefully evaluate the risk of cardiovascular problems before he/she lets you start treatment with EVENITY. Tell your doctor if you know that you have an increased risk of cardiovascular problems such as established cardiovascular disease, high blood pressure, high blood fat levels, diabetes, smoking or kidney problems. Low levels of calcium in the blood EVENITY may cause low levels of calcium in your blood. Tell your doctor if you notice: • spasms, twitches, or cramps in your muscles; • numbness or tingling in your fingers, toes or around your mouth. Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels in your blood before you start your treatment and while you take EVENITY. Take calcium and vitamin D as your doctor tells you to. Tell your doctor if you have or have ever had severe kidney problems, kidney failure or have needed dialysis as this may increase your risk of getting low blood calcium if you do not take calcium supplements. Draft
Serious allergic reactions Serious allergic reactions can happen to people who use EVENITY. Seek medical attention straight away if you get: • swelling of the face, mouth, throat, hands, feet, ankles, lower legs (angioedema), or hives; • acute skin eruption showing multiple round, red/pink spots with a blistering or crusting centre (erythema multiforme); • difficulty in swallowing or breathing. Problems with your mouth, teeth or jaw A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported rarely (may affect up to 1 in 1,000 people) in patients receiving EVENITY. ONJ can also occur after stopping treatment. It is important to try to prevent ONJ developing, as it may be a painful condition that can be difficult to treat. In order to reduce the risk of developing ONJ, there are some precautions you should take.
2
Before receiving EVENITY, tell your doctor or nurse if you: • have any problems with your mouth or teeth such as poor dental health, gum disease, or a planned tooth extraction; • do not receive routine dental care or have not had a dental check-up for a long time; • are a smoker (as this may increase the risk of dental problems); • have previously been treated with a bisphosphonate (used to treat or prevent bone disorders, such as osteoporosis); • are taking medicines called corticosteroids (such as prednisolone or dexamethasone); • have cancer. Your doctor may ask you to undergo a dental examination before you start treatment with EVENITY. 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 EVENITY. Contact your doctor and dentist immediately if you get any problems with your mouth or teeth such as: • loose teeth; • pain or swelling; • mouth sores that do not heal; • discharge. Unusual thigh bone fractures People who have used EVENITY rarely developed unusual fractures of the thigh bone caused by little or no trauma. These fracture types are often preceded by warning signs of thigh or groin pain for several weeks before the fracture occurs. It is not known whether EVENITY caused these unusual fractures. Tell your doctor or pharmacist if you get any new or unusual pains in your hip, groin or thigh. Draft
Children and adolescents The use of romosozumab in children and adolescents has not been studied and it is not approved for use in paediatric patients (age <18 years). Other medicines and EVENITY Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Pregnancy and breast-feeding EVENITY is only intended to treat women after menopause. EVENITY should not be used by women of child-bearing potential, or when pregnant or breastfeeding. It is not known whether EVENITY may harm an unborn or breast-fed child. Contact your doctor if you have any questions. Driving and using machines EVENITY is expected to have no effect or very little effect on the ability to drive and use machines. EVENITY contains sodium and polysorbate 20 This medicine contains 0.070 mg of polysorbate 20 in each pre-filled pen. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies. This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodiumfree'.
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3.
How to use EVENITY
EVENITY will be initiated and supervised by specialist physicians experienced in the management of osteoporosis. Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. The injection should only be given by a person who has been properly trained. How much to use • The recommended dose of EVENITY is 210 mg. • Since one pre-filled pen contains 105 mg of the active substance romosozumab in 1.17 ml of solution (90mg/ml), 2 pre-filled pens must be used for each dose. The second injection must be given immediately after the first one but at a different injection site. • Do this once every month for 12 months.
How to take it
• EVENITY has to be injected under the skin (sub-cutaneous injection). • EVENITY should be injected in either the stomach area (abdomen) or thigh. The outer area of your upper arm can also be used as an injection site, but only if someone else is giving you the injection. • If the same injection area is planned to be used for the second injection, a different injection spot should be used. • EVENITY should not be injected into areas where the skin is tender, bruised, red, or hard. It is important that you read the Instructions for Use for detailed information on how to use the EVENITY pre-filled pen. Ask your doctor or pharmacist if you have any further questions on the use of the medicine. If you use more EVENITY than you should If, by mistake, you have used more EVENITY than you should, contact your doctor or pharmacist. Draft
If you forget to use or cannot take EVENITY at your usual time If you miss a dose of EVENITY, contact your doctor as soon as possible to schedule another dose. Thereafter, the next dose should be given not earlier than one month after the date of the last dose. If you stop taking EVENITY If you are considering stopping EVENITY treatment, please discuss this with your doctor. Your doctor will advise you on how long you should be treated with EVENITY. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. Discuss with your doctor the need to switch to another osteoporosis treatment after the end of your treatment with EVENITY. 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Seek medical attention straight away if you get any of the following possible symptoms of heart attack or stroke (uncommon: may affect up to 1 in 100 people): • chest pain, shortness of breath; • headache, numbness, or weakness in your face, arms, or legs, difficulty talking, changes in vision, loss of balance.
4
Seek medical attention straight away if you get the following symptoms of a serious allergic reaction (rare: may affect up to 1 in 1,000 people): • swelling of the face, mouth, throat, hands, feet, ankles, lower legs (angioedema), or hives; • acute skin eruption showing multiple round, red/pink spots with a blistering or crusting centre (erythema multiforme); • difficulty in swallowing or breathing. Tell your doctor if you notice the following symptoms of low levels of calcium in the blood (hypocalcaemia) (uncommon: may affect up to 1 in 100 people): • spasms, twitches, or cramps in your muscles; • numbness or tingling in your fingers, toes or around your mouth. See also section 2 "What you need to know before you use EVENITY". Other side effects may include: Very common side effects (may affect more than 1 in 10 people): • Common cold; • Joint pain. Common side effects (may affect up to 1 in 10 people): • Rash, inflammation of the skin; • Headache; • Inflammation of the sinuses; • Neck pain; • Muscle spasms; • Redness or pain around the site where the injection was given. Draft
Uncommon side effects (may affect up to 1 in 100 people): • Hives (urticaria); • Cataract. 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: Yellow Card Scheme Website: 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. 5.
How to store it
EVENITY
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.
5
Once you take the carton containing the pre-filled pens out of the refrigerator for use, you should not put it back into the refrigerator but you can keep it at room temperature (up to 25°C) for up to 30 days. If not used within this period the product should be discarded. Keep the pre-filled pen in the outer carton in order to protect from light. Visually check the solution. Do not use it if the solution is discoloured, cloudy, or contains flakes or particles. 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 protect the environment. 6.
Contents of the pack and other information
What EVENITY contains –
The active substance is romosozumab. Each pre-filled pen contains 105 mg of romosozumab in 1.17 ml of solution (90mg/ml). The other ingredients are calcium acetate, glacial acetic acid, sodium hydroxide (for pH adjustment), sucrose, polysorbate 20 and water for injections. See section 2 "EVENITY contains sodium"
What EVENITY looks like and contents of the pack EVENITY is a clear to opalescent, colourless to light yellow solution for injection provided in a single use disposable pre-filled pen. The syringe inside the pen is made of plastic with a stainless steel needle. Pack size of 2 pre-filled pens. Multipack containing 6 (3 packs of 2) pre-filled pens. Not all pack sizes may be marketed. Draft
Marketing Authorisation Holder UCB Pharma Limited, 208 Bath Road, Slough, Berkshire, SL1 3WE, United Kingdom. Manufacturer Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, Netherlands This leaflet was last revised in September 2024
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Please turn over for the Instructions for Use. ———————————————————————————————————————–INSTRUCTIONS FOR USE FOR THE EVENITY INJECTION BY MEANS OF A PREFILLED PEN Inject two pre-filled pens one immediately after the other to get a full dose
= 1 dose
The following instructions explain how to use the pre-filled pen to inject EVENITY. •
Please read these instructions carefully and follow them step by step.
•
If you have any questions or you feel unsure about the injection procedure, please contact a doctor or pharmacist. It is important to make sure that the injection is only administered by an individual that has been properly trained. The pre-filled pen is also referred to as "the medicine". Draft
• •
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Guide to parts: pre-filled pen Before use
After use
Expiry date
Expiry date
Yellow window (injection complete)
Window
Medicine Yellow safety guard
White cap on Draft
White cap off
STOP
Read this before the medicine is injected. Your healthcare provider has prescribed a dose of 210 mg every month: To receive your full dose, two 105 mg prefilled pens should be injected, one immediately after the other.
8
+
= 1 dose
Step 1: Prepare A
• • • • • • •
•
B
C
Take the carton containing the two pre-filled pens out of the refrigerator. Your pre-filled pens should be left outside the refrigerator to reach room temperature (up to 25°C) for at least 30 minutes before injection (do not warm in any other way). This will make the injection more comfortable. Open the carton and gather all materials you need for the injection (as listed in Step B). Wash your hands thoroughly. Lift the pre-filled pens straight up out of the carton − do not remove the white caps from the prefilled pens yet. Do not shake the pre-filled pens. Check the medicine through the viewing window. The medicine should be a clear to opalescent, colourless to light yellow solution. Do not use the pre-filled pens if the solution is discoloured, cloudy, or contains flakes or particles. You may see air bubbles. Injecting the solution subcutaneously (under the skin) which contains air bubbles is harmless. Do not use the pre-filled pens if: it has been dropped; the white cap is missing or not securely attached; the seal is missing or broken or if any other part appears cracked or broken. In such case, use a new pen and contact your doctor as soon as possible.
On a clean, well-lit work surface, place: • two pre-filled pens; • two alcohol wipes; • two cotton balls or gauze pads; • two adhesives bandages; • special disposal container.
Draft
Prepare and clean the skin where you are going to inject the medicine. You can choose from:
- the thighs;
- the stomach area (abdomen), but not the 5 cm area Outer area of upper arm around the belly button; Stomach area
- the outer area of the upper arm (if someone else is (abdomen) giving you the injection). Thigh
• • •
The second injection should be given on a different site than the one used for the first injection. If you wish to use the same injection site, make sure it is not the exact same injection spot. Do not inject into areas where the skin is tender, bruised, red, hard, has scars, or stretch marks, or has raised thick, red, or scaly skin patches or lesions. Clean the area you are going to inject with an alcohol wipe. Let the skin dry before the injection.
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•
Do not touch this area again before injecting. Step 2: Get ready
D
•
Pull the white cap straight off just before the injection.
•
Once the cap is removed, the injection must be given within 5 minutes. There is no need to rush the injection – 5 minutes is enough time.
•
Do not twist or bend the white cap.
•
Discard the white cap in the special disposal container. Do not place the white cap back onto the pre-filled pen. Draft
•
E
Although hidden from view, the needle tip is now uncovered. Do not try to touch the needle as it could activate the pre-filled pen. It is normal to see a drop of liquid at the end of the needle (inside the yellow safety guard).
Stretch or pinch the injection site to create a firm surface. Stretch method •
Stretch the skin firmly by moving thumb and fingers in opposite directions, to create an area about 5 cm wide.
OR Pinch method 10
•
Pinch the skin firmly between thumb and fingers, to create an area about 5 cm wide.
•
Important: Keep the skin stretched or pinched while injecting.
Step 3: Inject F
•
Important: The pre-filled pen should not be pushed down until the actual injection is ready to be performed.
•
The stretch or pinch should be held. With the other hand, the pre-filled pen's yellow safety guard should be placed down on the area of the skin that previously has been cleaned (the "injection site") at a 90° degree angle.
Draft
Yellow safety guard
G
•
The pre-filled pen should be firmly pushed down onto the skin until the yellow safety guard stops moving. When you hear or feel a click, the injection will begin.
H
• •
Keep pushing down on the skin. The injection could take about 15 seconds. When the injection is complete, the viewing window will turn fully yellow and you may also hear or feel a second click.
Push down
"click"
11
15 seconds
"click"
Window turns fully yellow when injection is complete. • • •
The used pre-filled pen may now be removed by carefully pulling it straight up from the skin. Important: When you remove the pre-filled pen, if the window has not turned fully yellow, or if it looks like the medicine is still injecting, this means the full dose has not been delivered. Your healthcare provider should be informed as soon as possible. After removing the pre-filled pen from the skin, the needle will be automatically covered. Do not try to touch the needle.
Step 4: Dispose I
•
Discard the entire used pre-filled pen and the white cap in a special container straight away after use. Draft
• • •
Do not throw away (dispose of) the pre-filled pen in the household waste. Do not re-use the pre-filled pen. Important: Always keep the special disposal container out of the sight and reach of children. Step 5: Examine the injection site
J
If there is blood, use a cotton ball or a piece of gauze and apply light pressure over the injection site for a few seconds. Do not rub the injection site. The injection site can be covered with a small adhesive bandage, if necessary. Step 6: Repeat for the second injection to get the full dose
12
K
Repeat all steps starting from step C with the second pre-filled pen to inject the full dose. The second injection should be given on a different site than the one used for the first injection. If you wish to use the same injection site, make sure it is not the exact same injection spot.
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Draft
13
= 1 dose
Frequently asked questions about EVENITY 105 mg solution for injection in pre-filled pen
How do I take EVENITY 105 mg solution for injection in pre-filled pen?
EVENITY 105 mg solution for injection in pre-filled pen comes as injection containing 105mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in EVENITY 105 mg solution for injection in pre-filled pen?
The active substance in EVENITY 105 mg solution for injection in pre-filled pen is romosozumab.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for EVENITY 105 mg solution for injection in pre-filled pen, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get EVENITY 105 mg solution for injection in pre-filled pen without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: romosozumab
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
EVENITY is indicated in treatment of severe osteoporosis in postmenopausal women at high risk of fracture (see section 5.1).
4.2. Posology and method of administration
Treatment should be initiated and supervised by specialist physicians experienced in the management of osteoporosis.
Posology
The recommended dose is 210 mg romosozumab (administered as two subcutaneous injections of 105 mg each) once monthly for 12 months.
Patients should be adequately supplemented with calcium and vitamin D before and during treatment (see sections 4.3 and 4.4).
Patients treated with EVENITY should be given the package leaflet and the patient alert card.
Following completion of romosozumab therapy, transition to antiresorptive therapy is recommended in order to extend the benefit achieved with romosozumab beyond 12 months.
Missed doses
If the romosozumab dose is missed, it should be administered as soon as it can be feasible. Thereafter, the next romosozumab dose should not be given earlier than one month after the last dose.
Special populations
Elderly
No dose adjustment is necessary in elderly patients (see also section 5.2).
Renal impairment
No dose adjustment is required in patients with renal impairment (see section 5.2). Serum calcium should be monitored in patients with severe renal impairment or receiving dialysis (see section 4.4).
Hepatic impairment
No clinical trials have been conducted to evaluate the effect of hepatic impairment (see section 5.2).
Paediatric population
The safety and efficacy of romosozumab in paediatric patients (age <18 years) have not yet been established. No data are available.
Method of administration
Subcutaneous use
To administer the 210 mg dose, 2 subcutaneous injections of romosozumab should be given into the abdomen, thigh, or upper arm. The second injection should be given immediately after the first one but at a different injection site.
Administration should be performed by an individual who has been trained in injection techniques.
For instructions on handling and disposal see section 6.6.
4.3. Contraindications
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see section 4.4)
- Hypocalcaemia (see section 4.4)
- History of myocardial infarction or stroke (see section 4.4)
4.4. Special warnings and precautions for use
Myocardial infarction and stroke
In randomised controlled studies, an increase in serious cardiovascular events (myocardial infarction and stroke) has been observed in romosozumab treated patients compared to controls (see section 4.8).
Romosozumab is contraindicated in patients with previous myocardial infarction or stroke (see section 4.3).
When determining whether to use romosozumab for an individual patient, consideration should be given to her fracture risk over the next year and her cardiovascular risk based on risk factors (e.g. established cardiovascular disease, hypertension, hyperlipidaemia, diabetes mellitus, smoking, severe renal impairment, age). Romosozumab should only be used if the prescriber and patient agree that the benefit outweighs the risk. If a patient experiences a myocardial infarction or stroke during therapy, treatment with romosozumab should be discontinued.
Hypocalcaemia
Transient hypocalcaemia has been observed in patients receiving romosozumab.
Hypocalcaemia should be corrected prior to initiating therapy with romosozumab and patients should be monitored for signs and symptoms of hypocalcaemia. If any patient presents with suspected symptoms of hypocalcaemia during treatment (see section 4.8), calcium levels should be measured. Patients should be adequately supplemented with calcium and vitamin D (see sections 4.3 and 4.8).
Patients with severe renal impairment (estimated glomerular filtration rate [eGFR] 15 to 29 ml/min/1.73 m2) or receiving dialysis are at greater risk of developing hypocalcaemia and the safety data for these patients is limited. Calcium levels should be monitored in these patients.
Hypersensitivity
Clinically significant hypersensitivity reactions, including angioedema, erythema multiforme, and urticaria occurred in the romosozumab group in clinical trials. If an anaphylactic or other clinically significant allergic reaction occurs, appropriate therapy should be initiated and use of romosozumab should be discontinued (see sections 4.3 and 4.8).
Osteonecrosis of the jaw
Osteonecrosis of the jaw (ONJ), has been reported rarely in patients receiving romosozumab. The following risk factors should be considered when evaluating a patient's risk of developing ONJ:
- potency of the medicinal product that inhibits bone resorption (the risk increases with the antiresorptive potency of the compound), and cumulative dose of antiresorptive therapy.
- cancer, co-morbid conditions (e.g. anaemia, coagulopathies, infection), smoking.
- concomitant therapies: corticosteroids, chemotherapy, angiogenesis inhibitors, radiotherapy to head and neck.
- poor oral hygiene, periodontal disease, poorly fitting dentures, history of dental disease, invasive dental procedures e.g. tooth extractions.
All patients should be encouraged to maintain good oral hygiene, receive routine dental check-ups, and immediately report any oral symptoms such as dental mobility, pain or swelling or non-healing of sores or discharge during treatment with romosozumab.
Patients who are suspected of having or who develop ONJ while on romosozumab should receive care by a dentist or an oral surgeon with expertise in ONJ. Discontinuation of romosozumab therapy should be considered until the condition resolves and contributing risk factors are mitigated where possible.
Atypical femoral fractures
Atypical low-energy or low trauma fracture of the femoral shaft, which can occur spontaneously, has been reported rarely in patients receiving romosozumab. Any patient who presents with new or unusual thigh, hip, or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out an incomplete femur fracture. Patient presenting with an atypical femur fracture should also be assessed for symptoms and signs of fracture in the contralateral limb. Interruption of romosozumab therapy should be considered, based on an individual benefit-risk assessment.
Excipients
This medicine contains 0.070 mg of polysorbate 20 in each pre-filled pen and each pre-filled syringe. Polysorbates may cause allergic reactions.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium-free.
4.5. Interaction with other medicinal products and other forms of interaction
No drug interaction studies have been performed with romosozumab. No pharmacokinetic drug interactions are expected with romosozumab.
4.6. Fertility, pregnancy and lactation
Pregnancy
Romosozumab is not indicated for use in women of child-bearing potential or in pregnant women. There are no data from the use of romosozumab in pregnant women. Skeletal malformations (including syndactyly and polydactyly) were observed at a low incidence in a single study with romosozumab in rats (see section 5.3). A risk for malformations of developing digits in the human foetus is low following romosozumab exposure due to the timing of digit formation in the first trimester in humans, a period when placental transfer of immunoglobulins is limited.
Breast-feeding
Romosozumab is not indicated for use in breast-feeding women.
No data are available on excretion of romosozumab in human milk. Human IgGs are known to be excreted in breast milk during the first few days after birth, which is decreasing to low concentrations soon afterwards; consequently, a risk to the breast-fed infant cannot be excluded during this short period.
Fertility
No data are available on the effect of romosozumab on human fertility. Animal studies in female and male rats did not show any effects on fertility endpoints (see section 5.3).
4.7. Effects on ability to drive and use machines
Romosozumab has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile
The most common adverse reactions were nasopharyngitis (13.6%) and arthralgia (12.4%). Hypersensitivity-related reactions occurred in 6.7% of patients treated with romosozumab. Hypocalcaemia was reported uncommonly (0.4% of patients treated with romosozumab). In randomised controlled studies, an increase in serious cardiovascular events (myocardial infarction and stroke) has been observed in romosozumab treated patients compared to controls (see section 4.4 and information below).
Tabulated list of adverse reactions
The following convention has been used for the classification of the adverse reactions: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) and very rare (< 1/10,000). Within each frequency grouping and system organ class, adverse reactions are presented in order of decreasing seriousness.
MedDRA System Organ Class
Adverse reaction
Frequency category
Infections and infestations
Nasopharyngitis
Sinusitis
Very common
Common
Immune system disorders
Hypersensitivitya
Rash
Dermatitis
Urticaria
Angioedema
Erythema multiforme
Common
Common
Common
Uncommon
Rare
Rare
Metabolism and nutrition disorders
Hypocalcaemiab
Uncommon
Nervous system disorders
Headache
Strokec
Common
Uncommon
Eye disorders
Cataract
Uncommon
Cardiac disorders
Myocardial infarctionc
Uncommon
Musculoskeletal and connective tissue disorders
Arthralgia
Neck pain
Muscle spasms
Very common
Common
Common
General disorders and administration site conditions
Injection site reactionsd
Common
a. See sections 4.3 and 4.4.
b. Defined as albumin adjusted serum calcium that was below the lower limit of normal. See sections 4.3 and 4.4.
c. See section “Myocardial infarction and stroke” below.
d. Most frequent injection site reactions were pain and erythema.
Description of selected adverse reactions
Immunogenicity
In postmenopausal women dosed with monthly romosozumab, the incidence of anti-romosozumab antibodies was 18.6% (1162 of 6244) for binding antibodies and 0.9% (58 of 6244) for neutralizing antibodies. The earliest onset of anti-romosozumab antibodies was 3 months after first dosing. The majority of antibody responses were transient.
The presence of anti-romosozumab binding antibodies decreased romosozumab exposure by up to 25%. No impact on the efficacy of romosozumab was observed in the presence of antiromosozumab antibodies. Limited safety data show that the incidence of injection site reactions was numerically higher in female patients with neutralizing antibodies.
Myocardial infarction, stroke and mortality
In the active-controlled trial of romosozumab for the treatment of severe osteoporosis in postmenopausal women during the 12-month double-blind romosozumab treatment phase, 16 women (0.8%) had myocardial infarction in the romosozumab arm versus 5 women (0.2%) in the alendronate arm and 13 women (0.6%) had stroke in the romosozumab arm versus 7 women (0.3%) in the alendronate arm. These events occurred in patients with and without a history of myocardial infarction or stroke. Cardiovascular death occurred in 17 women (0.8%) in the romosozumab group and 12 (0.6%) women in the alendronate group. The number of women with major adverse cardiac events (MACE = positively adjudicated cardiovascular death, myocardial infarction or stroke) was 41 (2.0%) in the romosozumab group and 22 (1.1%) in the alendronate group, yielding a hazard ratio of 1.87 (95% confidence interval [1.11, 3.14]) for romosozumab compared to alendronate. All-cause death occurred in 30 women (1.5%) in the romosozumab group and 22 (1.1%) women in the alendronate group.
In the placebo-controlled trial of romosozumab for the treatment of osteoporosis in postmenopausal women (including women with severe and less severe osteoporosis) during the 12-month double-blind romosozumab treatment phase, there was no difference in positively adjudicated MACE; 30 (0.8%) occurred in the romosozumab group and 29 (0.8%) in the placebo group. All-cause death occurred in 29 women (0.8%) in the romosozumab group and 24 (0.7%) women in the placebo group.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
There is no experience with overdose in clinical trials. There is no known antidote to romosozumab or specific treatment for overdose. In case of overdose, it is recommended that patients are monitored closely and given appropriate treatment.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- EVENITY 105 mg prescriptionROMOSOZUMABUM · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- EvenityRomosozumabum · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about EVENITY 105 mg solution for injection in pre-filled pen. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.