Evenity: Uses, Side effects and Interactions

Overview

About Evenity

Evenity is an anabolic drug used by women to treat osteoporosis. It is a bone-building medication that reduces the risk of fracture and helps in building new bones in a span of 12 months.

Romosozumab is a monoclonal antibody. It promotes quicker and greater increase in density of bones. The generic name for Evenity is Romosozumab.

Romosozumab ¹Overview| Researched based study from Nlm.nih.gov is sold by Amgen with the brand name Evinity. Romosozumab became FDA approved in 2019.

How does it work?

Romosozumab is available under several brand names.

• Romosozumab is a humanized monoclonal antibody. It is manufactured by recombinant DNA technology via a mammalian cell line culture (Chinese Hamster Ovary).

• Sclerostin is a protein that doesn’t allow bone formation. Romosozumab will inhibit sclerostin, thus slowing down the loss of bone density and increasing the growth of bone tissue. It is also known to improve the architecture of the bone and improve bone strength. It reaches peak concentration by 2-7 days.¹Overview| Researched based study from Nlm.nih.gov

• Bone mineral density of the hip, lumbar spine and neck of femur increased significantly with the use of Evenity.

Uses

Uses of Evenity

In Osteoporosis treatment

Evenity is an FDA approved drug. It is used for the treatment of osteoporosis seen in postmenopausal females. It is used by women who have

• Higher chances of fracture.
• Are intolerant to other medications.
• Tried and tested other osteoporosis treatments for bone density that didn’t respond.

Evenity differs from other medications in a way that it treats bone loss and increases bone growth simultaneously.

According to the ACE guidelines Evenity therapy must be given if you notice:

• Fractures during ongoing osteoporosis treatment
• T score less than -3.0
• High probability of fractures
• High risk of injurious falls
• Multiple fractures
• Recent fracture (12 months)
• Intolerant to osteoporosis medication
• Failed treatment with bisphosphonates
• No history of stroke or heart attack ²Uses| Researched based study from Medicines.org.uk

Side effects

Side effects of Evenity

Severe side effects

Evenity has a few side effects. You must contact your doctor if you experience:

Heart attack

• It presents as chest pain, dizziness, shortness of breath and pain in the left shoulder.

Allergic reaction

• Swelling of the face, tongue, lips, presence of rashes, difficulty in swallowing and breathing.

Pain

• You might encounter dull or sharp pain in the hip,thigh or groin area.

Stroke

• Vision changes, headache, loss of balance, weakness, paralysis of one side of the body, numbness in the legs and arms are all signs of stroke.

Injection site reaction

• It will present with pain and redness at the junction of injection.

Other common side effects are:

• Headache
• Cold
• Joint pain
• Neck pain
• Muscle spasm
• Weakness
• Swelling in the arms and legs
• Difficulty in sleeping
• Swollen gums.
• Jaw pain
• Low calcium levels show faster heartbeat, cramps, tingling , twitching, muscle pain, seizures etc.

Forms

Forms of Evenity

• Evenity comes as a 1.17ml of sterile, clear, opalescent, light yellow preservative free solution in a pre-filled syringe.
• It is latex free and contains 105 mg of romosozumab. Inactive ingredients include calcium acetate, sucrose, sodium hydroxide, polysorbate 20 and water for injections.

Dosage

Dosage of Evenity

Total dose of 210 mg of Evenity is given in two different syringes

• Two pre-filled syringes containing 105 mg/1.17 mL are given subcutaneously in the thigh, abdomen or upper arm one after the other. It must be given under supervision by a healthcare professional only.

• Twelve monthly dosages are required to complete Evenity’s treatment. It is given once every month. Once the 12 months course is completed, you must continue the treatment for osteoporosis with other drugs to avoid bone fracture and fall.³Dosage| Researched based study from Amgen.com

In case of missed dose

• If you forget to take a dose, you must take it as soon as you remember. The next dose must be taken exactly one month after the injection of the missed dose.

In case of overdose

• If your doctor has given you a different dose than the ones mentioned here, don’t alter how you take the medicine without talking to your doctor first. Don’t inject double doses of Evenity to make up for the missed one.

Administration of Evenity

• Remove two syringes and check for the presence of discoloration or particulates in the Evenity solution ³Dosage| Researched based study from Amgen.com . It must be clear, colorless and yellow in appearance. Discard it if it appears cloudy or discolored with particles.
• Allow Evenity to settle at room temperature for about 30 minutes before you inject it. Do not heat or warm by other means.
• Prepare the two clean sites to be injected. The recommended injection sites are the thigh, upper arm, and abdomen (avoid two-inch area across the navel)
• Choose different sites of injection every time you give it. Do not administer the injection into body areas where the skin is scarred, hard or tender.
• Pull out the gray cap needle and inject the solution subcutaneously. Make sure that you don’t inject the solution into a blood vessel.
• Once you’re done, immediately discard the syringe with the needle cap.
• Evenity takes around 2 weeks for the bone to start forming and to slow down the bone break. It needs 1 year to notice the full effect of Evenity. You must stop using it after one year because the effect on bone growth decreases after 12 months.

Do not use the syringe

• If it is broken/cracked.
• If the gray needle top is missing or badly attached.
• If it has expired.³Dosage| Researched based study from Amgen.com

Storage

Storage

• Store Evenity in a fridge at 2-8°C in the original package. Do not shake or freeze it. Once you remove Evenity for injecting, you can keep it at a room temperature of 25°C. It must be utilized within 28 days. If it remains unused, then discard it.

Precautions

Precautions and warnings

Before you start with Evenity you must inform your doctor about any allergy or medical condition you have like:

Femur fracture

• If you have femur bone fracture (long bone) then you might experience some pain in the hip, thigh and groin area.

Calcium and Vitamin D

• These are the vital components of bone strength and growth. It is recommended to use vitamin D or calcium supplements to obtain the highest benefit of romosozumab. Correct hypocalcemia before initiating Evenity.

Cardiac issues

• Evenity has been linked with fatal and non fatal stroke and heart attack. If you have had an attack of stroke or heart attack in the past, you must inform your doctor and avoid using this medication. Any heart disease like heart failure, arrhythmia, angina will require proper monitoring by your doctor.

Jaw problems

• Associated with infection and delayed healing, Evenity causes severe jaw issues like pain and swelling. It is known as osteonecrosis of the jaw. Thus, good oral hygiene is necessary. You must visit your dentist before beginning this medication. Try to avoid invasive dental treatments like tooth extraction or even root canal.

Pregnancy

• It is recommended to avoid using Evenity in pregnancy. If you conceive while using this drug then contact your doctor immediately.³Precautions| Researched based study from Amgen.com

Breastfeeding

• Evenity is not recommended in females of reproductive age group. In a study, romosozumab was seen in the serum of offspring due to maternal gestational or Breastfeeding exposure.

Renal problems

• Women who are undergoing dialysis or have high renal impairment are at greater risk of acquiring hypocalcemia. No dose adjustment is needed. You should monitor calcium levels in patients who have renal impairment.

Geriatric use

• In a study ³Precautions| Researched based study from Amgen.com of 6544 postmenopausal osteoporotic women, 80% were aged 65 years and more and 37% of them were aged 75 years and more. There were no considerable differences in terms of safety or efficacy observed among these subjects.

Pediatric use

• The use of Evenity has not been studied in children.

Interactions

Drug interactions

• Drug interactions may interfere with the working of medications and increase the chances of side effects. Make a list of all prescription drugs, herbal drugs, non prescription drugs and vitamin supplements that you use. You must show this list to your doctor before beginning Evenity. Do not stop, start or alter the doses without doctor’s permission.

Contraindications

Evenity contraindications

Evenity is avoided if you have:

Hypocalcemia

• Correction of previously present hypocalcemia is necessary before initiating therapy with Evenity.

History of sensitivity

• A documented history of systemic allergic reactions to romosozumab or any of its components must be made. Adverse reactions observed are swelling, erythema multiforme, and urticaria.⁴Interactions| Researched based study from Fda.gov

Vs Prolia

Evenity vs Prolia

Evenity and Prolia are generally used for the treatment of osteoporosis. They are approved by the FDA for postmenopausal osteoporosis.

Key differences between Evenity and Prolia are:

Dosage

• Treatment with Evenity is restricted to once a month only while Prolia can be used once every 6 months.

Generic versions

• Evenity-not available as a biosimilar and its generic ingredient is Romosozumab.
• Prolia is also not available as a biosimilar and its generic ingredient is Denosumab.

Usage

• Evenity is solely used for postmenopausal osteoporosis treatment while Prolia can be used for osteoporotic treatment as well as for increasing bone mass in breast cancer and prostate cancer.

Warnings

• Evenity and Prolia share the same warnings ie. They can cause heart attack, renal impairment and stroke.

Side effects

• Severe pain is noticeable with Prolia but not with Evenity

Takeaway

Takeaway

Apparently 10 million women in the US have osteoporosis, which results in increased risk of hip, spine and wrist fractures. Thus, you must complete the full 12 month course of Evenity to notice effective results. Vitamin D and Calcium supplements are also given to sustain bone strength.

Patients who have suffered from a heart attack or stroke within the last year shouldn’t start taking Evenity. You must consider the potential of benefits topping the associated risks with heart health related risk factors. Discontinuation of Evenity is recommended in the event of a myocardial infarction or stroke occurring during therapy.