Movymia is a biosimilar medicine containing the active substance teriparatide, which acts like a natural parathyroid hormone to stimulate bone formation and reduce the risk of fractures in adults with osteoporosis. While generally well-tolerated, it is crucial for patients to understand the range of possible side effects before and during treatment. The severity and occurrence of these effects can vary from person to person.
Common Side Effects
Common side effects, affecting up to 1 in 10 patients, and very common side effects, affecting more than 1 in 10, include a variety of symptoms. Many are transient and mild, while others may warrant medical discussion if they persist or worsen.
- Very Common (more than 1 in 10 people): Pain in limbs, such as legs and arms.
- Common (up to 1 in 10 people):
- Nausea and vomiting.
- Headache.
- Dizziness or feeling faint, particularly upon standing (orthostatic hypotension).
- Injection site reactions (redness, swelling, pain, itching).
- High cholesterol levels.
- Depression.
- Increased sweating.
- Muscle cramps and joint pain.
- Fatigue and tiredness.
- Heartburn.
- Shortness of breath.
Serious and Rare Side Effects
Though less frequent, Movymia can cause more severe side effects that require immediate medical attention. Awareness of these risks is essential for patient safety.
- Hypercalcemia: A transient, slight increase in blood calcium levels can occur. However, symptoms of high calcium, such as confusion, persistent nausea, vomiting, constipation, muscle weakness, and increased thirst or urination, should be reported to your doctor immediately.
- Orthostatic Hypotension: A sudden drop in blood pressure when standing up can cause dizziness, lightheadedness, or fainting. It is advisable to sit or lie down after the first few injections until you know how your body reacts.
- Allergic Reactions: Severe allergic reactions are rare but can be life-threatening. Symptoms include hives, rash, swelling of the face, lips, or tongue, and difficulty breathing. Seek emergency medical help if these occur.
- Risk of Osteosarcoma: During early animal studies, very high doses of teriparatide were linked to an increased risk of osteosarcoma (bone cancer). However, human studies, including a large post-marketing review, have not shown an increased risk in humans. Nonetheless, patients with pre-existing bone cancer or a history of skeletal radiation therapy should not use Movymia.
Injection Site Reactions
Injection site reactions are a common, localized side effect of Movymia. These may include:
- Redness and swelling
- Pain or discomfort
- Itching or bruising
- Minor bleeding
These symptoms typically resolve within a few days or weeks. If they become severe or do not improve, consult your doctor.
Comparison of Side Effect Frequency
This table provides a quick reference for the frequency of reported side effects based on clinical trial data and post-marketing surveillance.
Side Effect Category | Frequency (Reported) | Examples | Sources |
---|---|---|---|
Very Common | > 1 in 10 people | Pain in limb, nausea | |
Common | 1 in 10 people | Headache, dizziness, depression, fatigue, injection site reactions, hypercholesterolemia, heartburn | |
Uncommon | 1 in 100 people | Increased heart rate, abnormal heart sound, weight increase, kidney stones, increased blood uric acid, leg cramps | |
Rare | 1 in 1,000 people | Reduced kidney function, swelling (mainly in hands, feet, legs), allergic reactions |
Who Should Not Use Movymia (Contraindications)
Movymia is not suitable for all patients with osteoporosis. Contraindications include:
- Allergy to teriparatide or any other ingredients.
- Pre-existing high blood calcium levels (hypercalcemia).
- Severe kidney problems.
- Metabolic bone diseases other than primary osteoporosis.
- Unexplained high alkaline phosphatase levels.
- Prior radiation therapy involving the bones.
- Skeletal malignancies or bone metastases.
- Pregnancy or breastfeeding.
- Children and adolescents whose bones are still growing.
Managing and Reporting Side Effects
Open communication with your healthcare provider is key to safely managing Movymia treatment. Here are some steps you can take:
- Inform your doctor: If you experience any persistent or concerning side effects, let your doctor know. They may adjust your treatment plan or offer advice.
- Manage dizziness: For orthostatic hypotension, get up slowly from a sitting or lying position. Inject the first few doses in a location where you can sit or lie down immediately if needed.
- Report serious symptoms: If you have symptoms of a serious allergic reaction, hypercalcemia, or unusual bone pain, seek immediate medical attention.
- Proper administration: Ensure you follow the correct injection technique to minimize injection site discomfort. Rotate injection sites and use a new needle for each dose.
- Report new safety information: As a monitored medicine, patients are encouraged to report any suspected adverse reactions via the national reporting system, which helps identify new safety information.
Conclusion
Movymia offers a valuable treatment for severe osteoporosis by stimulating bone formation, but like all medications, it comes with a range of side effects. Most are mild and manageable, such as pain in limbs, nausea, and dizziness, while serious adverse events like hypercalcemia and severe allergic reactions are rare. Although animal studies raised concerns about osteosarcoma, human studies have not confirmed this risk, and the medication is contraindicated in patients with pre-existing bone conditions. Patients should discuss all potential risks with their doctor to ensure it is the right treatment and to manage any side effects effectively throughout the recommended 24-month course. For more detailed information on teriparatide, you can also consult resources like the European Medicines Agency (EMA) product information.