Romosozumab

Romosozumab is a prescription medicine used to treat the symptoms of osteoporosis in postmenopausal women at high risk for fracture.

• Romosozumab is available under the following different brand names: Evenity, romosozumab-aqqg

Adult dosage

Injectable solution

• 105mg/1.17mL (single-use prefilled syringe)
• Syringe should not be made with natural rubber latex

Osteoporosis

Adult dosage

• 210 mg SC every month x 12 months
• Adequately supplement patient with calcium and vitamin D during treatment

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Romosozumab include:

• headache,
• joint pain,
• arthralgia
• hypersensitivity, and
• injection site reactions.

Serious side effects of Romosozumab include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• fever,
• sore throat,
• burning eyes,
• skin pain,
• red or purple skin rash with blistering and peeling,
• chest pain or pressure,
• shortness of breath,
• lightheadedness,
• sudden numbness or weakness,
• problems with vision or speech,
• loss of balance,
• new or unusual pain in the thigh, hip, or groin,
• jaw pain or numbness,
• red or swollen gums,
• loose teeth,
• infected gums,
• muscle spasms or contractions, and
• numbness or tingly feeling around the mouth, or in the fingers or toes.

Rare side effects of Romosozumab include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Romosozumab has no noted severe interactions with any other drugs.
• Romosozumab has no noted serious interactions with any other drugs.
• Romosozumab has no noted moderate interactions with any other drugs.
• Romosozumab has no noted minor interactions with any other drugs. 

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Hypocalcemia; preexisting hypocalcemia must be corrected before initiating
• Systemic hypersensitivity (e.g., angioedema, erythema multiforme, urticaria)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Romosozumab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Romosozumab?”

Cautions

• A higher rate of MACE, a composite endpoint of CV death, nonfatal MI, and nonfatal stroke was observed in a randomized controlled trial in postmenopausal women treated with romosozumab compared with alendronate; monitor for signs and symptoms of myocardial infarction and stroke and instruct patients to seek prompt medical attention if symptoms occur
• Hypersensitivity reactions reported, including angioedema, erythema multiforme, dermatitis, rash, and urticaria; discontinue the drug and initiate appropriate treatment if anaphylaxis or other clinically significant allergic reaction occurs
• Hypocalcemia reported; correct hypocalcemia before initiating; monitor for signs and symptoms of hypocalcemia; ensure adequate supplementation with calcium and vitamin D during therapy
• Atypical subtrochanteric and diaphyseal femoral fractures
  • Atypical low-energy or low-trauma femoral shaft fractures reported; many patients report prodromal pain in the affected area, usually presenting as dull, aching thigh pain, weeks to months before a complete fracture occurs
  • Femoral fractures: During treatment, patients should be advised to report new or unusual thigh, hip, or groin pain; any patient who presents with thigh or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out an incomplete femur fracture
  • A patient presenting with an atypical femur fracture should also be assessed for symptoms and signs of fracture in the contralateral limb; interruption of therapy should be considered based on benefit-risk assessment
• Osteonecrosis of the jaw
  • ONJ, which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing and has been reported in patients receiving romosozumab
  • Perform routine oral examination before initiating treatment; concomitant administration of drugs associated with ONJ (chemotherapy, bisphosphonates, denosumab, angiogenesis inhibitors, and corticosteroids) may increase ONJ risk
  • Other risk factors include cancer, radiotherapy, poor oral hygiene, preexisting dental disease or infection, anemia, and coagulopathy
  • For patients requiring invasive dental procedures, clinical judgment of the treating physician and/or oral surgeon should guide the management plan
  • Discontinuation should be considered based on benefit-risk assessment

Pregnancy and Lactation

• Not indicated for use in women of reproductive potential
• In animal reproduction studies, weekly administration to pregnant rats during the period of organogenesis at exposures above 32 times the clinical exposure produced skeletal abnormalities in the offspring
• Administration to rats before mating and through to the end of lactation produced minimal-to-slight decreases in femoral bone mineral density and/or cortical circumferences in the offspring at 1.5-56 times the expected exposure in humans
• Lactation
  • Not indicated for use in women of reproductive potential