Evenity
Pronunciation: E-ven-i-tee
Generic name: romosozumab [ ROE-moe-SOZ-ue-mab ]
Dosage form: subcutaneous injection (105 mg/1.17 mL)
Drug class: Miscellaneous bone resorption inhibitors
What is Evenity?
Evenity (romosozumab) injection is a prescription medicine used for osteoporosis to reduce the risk of bone fractures, in menopausal women. Evenity works by helping build new bone and reducing bone loss, this improves bone mineral density and helps to reduce spine fracture risk.
Evenity is given as two injections under the skin (subcutaneous) once a month for 12 months by your healthcare professional (HCP). You should also take calcium and vitamin D supplements while using the medicine. After finishing your 12 month treatment talk to your healthcare professional about follow-up options to help preserve the bone you’ve gained.
Evenity works (mechanism of action) by blocking sclerostin, a small protein that reduces bone formation. When Evenity injection blocks sclerostin, it increases the amount of bone being built and reduces the amount of bone being broken down, so bone density increases. Evenity injection is from a class of medicines called sclerostin inhibitors.
Evenity FDA approval is for the treatment of osteoporosis in postmenopausal women at high risk for fracture. This risk is defined as having a history of osteoporotic fracture or multiple risk factors for fracture or patients who have failed or are intolerant to other available osteoporosis therapies.
What is postmenopausal osteoporosis?
Postmenopausal osteoporosis is a condition in which bones become thinner, less dense, and weaker after menopause, increasing the risk of bone fractures. Changes in the body after menopause can speed up bone loss, making osteoporosis worse. Postmenopausal osteoporosis is a progressive condition. Evenity osteoporosis treatment for postmenopausal women helps to regain bone density in the spine, hip, and top of the thigh bone and reduces spine fracture risk after one year of treatment.
How well does Evenity work?
In the clinical trial called Study 1 (NCT01575834) Evenity significantly reduced the risk of vertebral fractures and increased bone mineral density (BMD).
Fracture Risk Reduction
- Vertebral fractures:
- 73% relative risk reduction at 12 months
- 75% relative risk reduction at 24 months (1 year on Evenity, then 1 year on denosumab)
Bone Mineral Density (BMD) Improvement
- In a 12-month placebo-controlled trial with 7,180 women:
- Lumbar spine BMD increased by 12.7%
- Total hip BMD increased by 5.8%
- Femoral neck BMD increased by 5.2%
These results confirm that Evenity significantly enhances bone strength and lowers fracture risk in postmenopausal women with osteoporosis.
Evenity side effects
Common Evenity side effects
Common Evenity side effects include:
- Joint pain (13.1%)
- Headache (6.6%)
- Muscle spasms (4.6%)
- Swelling of feet or hands (2.4%)
- Lack of energy and strength (2.3%)
- Neck pain (2.2%)
- Insomnia (2.0%)
- Feeling of pins and needles (2%)
These were the common side effects that occurred in 2% or more of patient on Evenity in Study 1 (NCT01575834).
Serious Evenity side effects
Get emergency medical help if you have signs of an allergic reaction (hives, difficulty breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
Seek emergency medical help if you have symptoms of a heart attack or stroke: chest pain or pressure, shortness of breath, feeling light-headed, sudden numbness or weakness, problems with vision or speech, or loss of balance.
Evenity may cause other serious side effects. Call your doctor at once if you have:
- new or unusual pain in your thigh, hip, or groin which may be a symptom of unusual thigh bone fractures,
- jaw pain or numbness, red or swollen gums, loose teeth, or infected gums which may be symptoms of osteonecrosis, or
- low calcium level with symptoms of muscle spasms or contractions, numbness or tingly feeling (around your mouth, or in your fingers and toes).
This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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Warnings
Evenity can increase your risk of having a heart attack or stroke, or dying from a heart or blood vessel problem. Seek emergency medical help if you have symptoms such as: chest pain or pressure, shortness of breath, feeling light-headed, sudden numbness or weakness, problems with vision or speech, or loss of balance.
You should not use this medicine if you have low levels of calcium in your blood (hypocalcemia). You may not be able to use romosozumab if you have had a heart attack or stroke within the past 12 months.
Before taking this medicine
You should not be treated with Evenity injection if you are allergic to the active ingredient romosozumab, any of the inactive ingredients or if you have low levels of calcium in your blood (hypocalcemia).
You may not be able to receive Evenity injection if you have had a heart attack or stroke within the past 12 months.
This medicine can increase your risk of having a heart attack or stroke or dying from a heart or blood vessel problem. Ask your doctor about your specific risk.
To make sure Evenity is safe for you, tell your doctor if you have ever had:
- heart problems;
- a blood vessel disorder;
- a stroke or heart attack;
- low levels of calcium in your blood (hypocalcemia);
- kidney disease (or if you are on dialysis);
- have appointment or plans to have teeth removed or any dental surgery, or
- if you cannot take calcium and vitamin D supplements every day.
This medicine may cause jaw bone problems (osteonecrosis). The risk is highest in people with cancer, blood cell disorders, pre-existing dental problems, or people treated with steroids, chemotherapy, or radiation. Ask your doctor about your own risk.
You may need to have a dental exam before you start treatment with Evenity. Follow your doctor's instructions.
Pregnancy and breastfeeding
Evenity should not be used in pregnancy. Evenity is for use only in women who can no longer get pregnant.
This medicine is also not for use while breastfeeding.
How is Evenity administered?
Evenity is administered as an injection under the skin of your stomach, upper thigh, or upper arm by a healthcare provider. Evenity is usually given as 2 injections under the skin (subcutaneous) once per month for 1 year.
Evenity injection is only part of a complete treatment program that may include taking daily calcium and vitamin D supplements. Take only the amount your doctor has prescribed.
Pay special attention to your dental hygiene. Brush and floss your teeth regularly while receiving this medicine. If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are receiving this medicine.
If you keep Evenity at home, store it in the original container in a refrigerator. Protect from light and do not freeze.
Take the medicine out of the refrigerator and let it reach room temperature for 30 minutes before your healthcare provider injects your dose. Do not heat Evenity in a microwave or with hot water.
Do not shake the prefilled syringe or you may ruin the medicine. Do not use the medicine if it looks cloudy or has particles in it. Call your pharmacist for a new prescription.
Each prefilled syringe is for one use only. Throw it away after one use, even if there is still medicine left inside.
After a prefilled syringe has reached room temperature, it must be used within 30 days or thrown away. Store in the original container away from heat and light.
Place used needles and syringes in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.
Evenity dosing information
Usual Adult Evenity Dose:
- 210 mg subcutaneously once a month
- Two injections of 105 mg each (one after the other), it is injected into the abdomen, thigh, or upper arm.
- This drug should be administered by a healthcare provider.
Duration of therapy:
- 12 months
Calcium and vitamin D supplements:
- Patients should also take adequate calcium and vitamin D supplementation during therapy.
- Women received at least 500 mg of calcium and 600 international units of vitamin D supplementation daily in Study 1.
- 77% of women received a loading dose of 50,000 to 60,000 international units of vitamin D within one week of randomization if serum 25-hydroxyvitamin D concentrations were 40 ng/mL or less.
After finishing your 12-month treatment:
- The effect of this drug declines after 12 months and so treatment is limited to 12 monthly doses.
- Your healthcare professional may consider the use of follow-up treatment for your osteoporosis if needed.
Evenity Package Insert
HCPs and patients often use the Evenity Package Insert (PI) for more detailed information about this medicine. The Package Insert contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions you have with your HCP (health care professional). This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.
The Package Insert is sometimes called Prescribing Information (PI) or FDA label.
Evenity J code
Evenity J code is J3111.
J codes are used for billing and reimbursement purposes and are specifically used for medicines that are not taken orally and includes injections, inhalations and chemotherapies. Your physician will need the Evenity J code when filling out your treatment forms.
What happens if I miss a dose?
Call your doctor for instructions if you miss a dose, or if you miss an appointment for your Evenity injection. You should receive your missed injection as soon as possible.
What happens if I overdose?
Since the Evenity prefilled syringe contains a specific amount of the medicine, you are not likely to receive an overdose.
What should I avoid while using Evenity?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
What other drugs will affect Evenity?
Other drugs may interact with romosozumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Storage
- Refrigerate at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Do not shake.
- If removed from the refrigerator, an injection can be kept at room temperature up to 25°C (77°F) in the original carton and must be used within 30 days. If not used within 30 days, discard.
- Do not expose injections to temperatures above 25°C (77°F).
Ingredients
Active ingredient: romosozumab-aqqg
Inactive ingredients: acetate, calcium, polysorbate 20, sodium hydroxide, sucrose and water for injection.
Company
Manufacturer Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320-1799
Evenity Biosimilars
Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.
Reference products
These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Evenity.
Evenity (romosozumab-aqqg) - Amgen Inc.
Formulation type | Strength |
---|---|
Pre-Filled Syringe | 105 mg/1.17 mL |
Popular FAQ
Evenity vs Prolia: Which is right for you?
Evenity (romosozumab-aqqg) and Prolia (denosumab) are two injectable medications that help lower the risk of bone fracture. When deciding which treatment option is best for you, it is important to consider factors such as who these medications are approved for, dosing, and side effects. Continue reading
What happens when you stop Evenity?
Within months of stopping Evenity (romosozumab), its effects on bone formation and resorption will diminish. Studies suggest that if you stop taking Evenity after three months, it can stay in the body for about 2 months. However, it can take up to 12 months for P1NP and CTX levels to return to what they were before you started treatment. Continue reading
Does Evenity cause dental problems?
Evenity (romosozumab) can rarely cause osteonecrosis of the jaw (ONJ), a rare but serious side effect. This condition occurs when there is loss of blood supply to the jaw. As a result, the jawbone is exposed and bone cells die. Continue reading
What is the billing J Code for Evenity?
Evenity J code is J3111. Continue reading
How does Evenity work?
Evenity (romosozumab-aqqg) is a humanized monoclonal antibody that works by inhibiting the activity of sclerostin, which is a small protein found in osteocytes. It increases bone formation and reduces bone loss. Continue reading
References
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- Drug class: miscellaneous bone resorption inhibitors
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Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.