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Prolia is a medication that contains denosumab as its active ingredient. It is associated with several side effects, which may vary depending on the condition being treated and the patient's characteristics. One of the most common side effects of Prolia is muscle pain, which can manifest as leg cramps. Leg cramps may be related to hypocalcemia (low calcium levels in the blood), which is a known side effect of Prolia. Additionally, Prolia has been linked to an increased risk of fractures in the thigh bone, which could also contribute to leg muscle cramps.
| Characteristics | Values |
|---|---|
| Leg muscle cramps | Low blood calcium levels (hypocalcemia) |
| Allergic reactions | |
| Thigh bone fractures | |
| Swelling in the legs |
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What You'll Learn
Hypocalcemia (low blood calcium)
Prolia (denosumab) is a prescription medicine approved to treat postmenopausal women with osteoporosis at high risk of bone fracture. It is also approved to treat men with osteoporosis, glucocorticoid-induced osteoporosis, and bone loss in men receiving androgen deprivation therapy for prostate cancer. Prolia works by blocking a protein called RANK (receptor activator of nuclear factor kappa beta), which helps prevent bone cells called osteoclasts from breaking down bones.
Prolia may lower the calcium levels in your blood, leading to hypocalcemia. This is a condition characterised by low blood calcium levels, which can be severe in patients with advanced chronic kidney disease (CKD), particularly those on dialysis. Patients with CKD who also have a condition known as mineral and bone disorder (CKD-MBD) are at a higher risk of developing severe hypocalcemia.
Symptoms of hypocalcemia include unusual tingling or numbness in the hands, arms, legs, or feet; painful muscle spasms or cramps; voice box or lung spasms causing difficulty breathing; vomiting; seizures; or irregular heart rhythm. In some cases, hypocalcemia may be asymptomatic, or without symptoms. However, when symptoms are present, they can also include confusion, fainting, face twitching, uncontrolled muscle spasms, weakness, or numbness in parts of the body.
If you are experiencing any symptoms of hypocalcemia, it is important to seek medical attention. Additionally, patients should not stop Prolia treatment without consulting a healthcare professional, as stopping may worsen your bone condition.
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Allergic reactions
Prolia (denosumab) may cause allergic reactions in some patients. However, it is unclear whether this side effect occurred in clinical studies. Nonetheless, patients should be aware of the possibility of allergic reactions and seek immediate medical attention if they experience any of the following symptoms:
- Itchiness
- Rashes
- Dizziness or lightheadedness
- Trouble breathing
- Tightness in the throat
- Swelling of the face, tongue, and throat
- Fainting
In addition to these allergic reactions, Prolia may also cause skin-related side effects such as rashes and dry skin. It is important to note that these side effects typically occur away from the injection site. Patients should inform their doctor or nurse immediately if they experience any of these symptoms. Furthermore, the needle cover of the prefilled Prolia syringe contains dry natural rubber, a derivative of latex, which may cause allergic reactions in individuals sensitive to latex. Therefore, it is crucial to inform your doctor of any latex allergies before starting treatment with Prolia.
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Thigh bone fractures
Prolia may cause leg muscle cramps due to hypocalcaemia (low calcium in the blood). This can cause muscle spasms or twitching, and numbness or tingling in the fingers, toes, or mouth. Prolia may also increase the risk of developing fractures of the thigh bone, which can cause muscle pain.
The thigh bone, or femur, is the longest and strongest bone in the human body. It usually takes a lot of force to break it, such as in a motor vehicle collision or a fall from a height. Femur fractures can also occur in the elderly, even from a simple fall from a standing position, as bones tend to become weaker with age.
Femur fractures can be classified according to the location and nature of the break. A proximal femur fracture is a break in the uppermost part of the thigh bone, next to the hip joint. A distal femur fracture occurs in the lower part of the thigh bone, just above the knee joint, and may involve the knee's cartilaginous surface. A femoral shaft fracture is a break anywhere along the long, straight part of the femur.
The most common types of femoral shaft fractures include transverse, oblique, spiral, and comminuted fractures. Transverse fractures are characterised by a straight horizontal break across the shaft. Oblique fractures present as an angled line across the shaft. Spiral fractures occur when a twisting force is applied to the thigh, resulting in a fracture line that encircles the shaft. Comminuted fractures are complex breaks where the bone shatters into three or more pieces.
Open fractures, where the bone punctures the skin, often result in extensive damage to the surrounding muscles, tendons, and ligaments. Closed fractures, on the other hand, are breaks where the skin remains intact.
Femur fractures typically require surgery to realign the bones and promote healing. In some cases, external or internal fixation methods are used to stabilise the fracture. External fixation involves inserting metal pins through the skin into the fractured bone, which are then attached to a bar outside the skin to hold the bone fragments in place. Internal fixation can be achieved through intramedullary nailing, where a metal rod is inserted into the marrow canal of the femur to secure the broken fragments. Another internal fixation technique utilises plates and screws to realign and hold the bone fragments together.
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Muscle pain
Prolia can cause muscle pain, which often contributes to back pain. This is one of the most common side effects reported in clinical trials of the drug. The muscle pain associated with Prolia is usually mild or manageable for most people. However, some postmenopausal women who received Prolia for osteoporosis had to stop treatment due to back pain.
Mild muscle pain can often be relieved with over-the-counter (OTC) pain medication, such as acetaminophen (Tylenol), naproxen (Aleve), or ibuprofen (Advil, Motrin). If OTC medications do not provide relief, a doctor may suggest prescription pain medication or physical therapy.
Prolia may also cause hypocalcaemia (low calcium in the blood), which can lead to muscle spasms or cramps. It is important to address low blood calcium before starting Prolia treatment, as it may worsen during treatment. Doctors may prescribe calcium and vitamin D supplements to help maintain adequate calcium levels while taking Prolia. Patients should monitor their calcium levels closely and report any signs of very low calcium, such as muscle spasms or cramps, to their doctor.
In rare cases, Prolia may cause fractures of the thigh bone, which can feel like a dull ache in the hip, thigh, or groin. Patients experiencing these symptoms should consult their doctor immediately.
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Back pain
Prolia (denosumab) is a prescription medicine used to treat osteoporosis and increase bone mass in people at high risk of fractures. It is also used to prevent bone fractures in people with breast or prostate cancer who are taking certain medications.
If you experience back pain while using Prolia, it is important to talk to your doctor. They may recommend treatment options, such as over-the-counter (OTC) pain medications like ibuprofen or acetaminophen. It is advised not to stop, skip, or delay taking Prolia without first consulting your doctor, as doing so can increase the risk of bone fractures.
Additionally, Prolia may cause other side effects, including joint pain, tooth and jaw-related issues, muscle pain, and increased cholesterol levels. It is important to be diligent about oral hygiene and regularly visit a dentist while using Prolia to mitigate the risk of dental and jaw-related side effects.
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Frequently asked questions
Prolia may cause leg muscle cramps due to hypocalcaemia (low calcium in the blood). It is important to treat low blood calcium before taking Prolia and to monitor calcium levels closely during treatment.
Common side effects of Prolia include back pain, arm pain, muscle pain, joint pain, high cholesterol, bladder infection, and fatigue.
It is not always clear when side effects from Prolia will start. Some people experience mild pain in their back, arms, legs, muscles, or joints immediately, while others might have more severe pain that can happen days or even months after the injection.
Yes, Prolia may cause serious allergic reactions, including anaphylaxis, which can be life-threatening. Other serious side effects include increased risk of fractures in the thigh bone and new malignancies.
If you experience any side effects from Prolia, it is important to talk to your doctor or pharmacist. They may recommend over-the-counter pain relievers or prescription medication to manage the symptoms. Do not stop taking Prolia without first consulting your doctor.
