Applies to romosozumab: subcutaneous solution.

Serious side effects of Romosozumab

Along with its needed effects, romosozumab may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking romosozumab:

More common

• Fast heartbeat
• fever
• hives, itching, skin rash
• hoarseness
• irritation
• joint pain, stiffness, or swelling
• redness of the skin
• swelling of the eyelids, face, lips, hands, or feet
• tightness in the chest
• troubled breathing or swallowing

Less common

• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• rapid weight gain
• tingling of the hands or feet
• unusual weight gain or loss

Rare

• Chest pain or discomfort
• confusion
• difficulty in breathing
• difficulty in speaking
• double vision
• headache
• heavy jaw feeling
• inability to move the arms, legs, or facial muscles
• inability to speak
• irregular heartbeat
• limp
• loosening of a tooth
• mood or mental changes
• muscle cramps in the hands, arms, feet, legs, or face
• nausea
• numbness and tingling around the mouth, fingertips, or feet
• pain or discomfort in the arms, jaw, back, or neck
• pain, swelling, or numbness in the mouth or jaw
• pain, swelling, tenderness, and bruising in your thigh
• seizures
• slow speech
• stomach cramps
• sweating
• tremor
• vomiting

Other side effects of Romosozumab

Some side effects of romosozumab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Difficulty in moving
• muscle pain or stiffness

Less common

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• lack or loss of strength
• trouble sleeping

For Healthcare Professionals

Applies to romosozumab: subcutaneous solution.

General

The most commonly reported adverse reactions have included arthralgia and headache.^[Ref]

Cardiovascular

During clinical trials, this drug increased the risk of cardiovascular death, heart attack and stroke in the compared with alendronate, but not compared with placebo; myocardial infarction occurred in 16 (0.8%) women receiving this drug compared to 5 (0.2%) receiving alendronate and stroke in 13 (0.5%) and 7 (0.3%) patients receiving this drug and alendronate, respectively. These events occurred in women with and without a history of MI or stroke. Cardiovascular death occurred in 17 (0.8%) and 12 (0.6%) of patients receiving this drug and alendronate, respectively. Positively adjudicated MACE (major adverse cardiac events; composite endpoint of cardiovascular death, nonfatal MI and nonfatal stroke) was significantly different at 41 (2%) and 22 (1.1%) in patients receiving this drug and alendronate respectively.

In the placebo-controlled trial, the number of women with positively adjudicated MACE was not significantly different with both groups reporting 0.8%.

Common (1% to 10%): Peripheral edema

Uncommon (0.1% to 1%): Myocardial infarction, myocardial death

Nervous system

Nervous system

Common (1% to 10%): Headache, paresthesia

Uncommon (0.1% to 1%): Stroke

During clinical trials, this drug increased the risk of cardiovascular death, heart attack and stroke in the alendronate trial, but not in the placebo trial; myocardial infarction occurred in 16 (0.8%) women receiving this drug compared to 5 (0.2%) receiving alendronate and stroke in 13 (0.5%) and 7 (0.3%) of patients receiving this drug and alendronate, respectively. These events occurred in women both with and without a history of MI or stroke. Positively adjudicated MACE (major adverse cardiac events; composite endpoint of cardiovascular death, nonfatal MI and nonfatal stroke) was significantly different at 41 (2%) and 22 (1.1%) in patients receiving this drug and alendronate respectively.

In the placebo-controlled trial, the number of women with positively adjudicated MACE was not significantly different with both groups reporting 0.8%.

Hypersensitivity

Common (1% to 10%): Hypersensitivity reactions (angioedema, erythema multiforme, dermatitis, rash, urticaria)

Hypersensitivity reactions were reported in 6.5% of women in clinical trials; reactions included angioedema and erythema multiforme in less than 0.1%, dermatitis (0.6%), rash (1.1%), and urticaria (0.4%).

Local

Common (1% to 10%): Injection site reactions

Injection site reactions occurred in 278 (4.9%) of patients and included injection site pain (1.7%) and erythema (1.4%).

Musculoskeletal

Osteonecrosis of the jaw occurred in 1 patient receiving this drug during clinical trials. Atypical femoral fracture also occurred in 1 patient.

Very common (10% or more): Arthralgia (up to 13.1%)

Common (1% to 10%): Muscle spasms, neck pain

Very rare (less than 0.01%): Osteonecrosis of the jaw, atypical femoral fracture

Other

Common (1% to 10%): Asthenia

Psychiatric

Common (1% to 10%): Insomnia

Immunologic

During clinical trials, 18.1% of the 5914 postmenopausal women receiving this drug developed antibodies; 4.7% had antibodies classified as neutralizing. Development of antibodies was associated with lower serum drug concentrations, however, was not associated with changes in safety and efficacy.

Very common (10% or more): Anti-drug antibodies (18.1%)

Metabolic

Uncommon (0.1% to 1%): Hypocalcemia

In clinical trials, 2 women receiving this drug experienced hypocalcemia. Decreases in albumin adjusted serum calcium to less than 8.3 mg/dL were reported in 14 (0.2%) women; there were no reports of adjusted serum calcium less than 7.5 mg/dL. The nadir in albumin-adjusted serum calcium occurred by month 1 in patients with normal renal function.