Prolia 60mg PFS Injection

Prolia 60mg PFS Injection contains Denosumab (60mg/ml), a monoclonal antibody that targets specific proteins to treat osteoporosis and bone loss in various patient populations.

Benefits

Prolia 60mg PFS Injection helps strengthen bones and significantly reduces the risk of fractures, including vertebral, non-vertebral, and hip fractures. It works by slowing down bone breakdown and increasing bone density, contributing to stronger, healthier bones.

Uses and Indications

• Treatment of osteoporosis in postmenopausal women at increased risk of fractures.
• Treatment to increase bone mass in men with osteoporosis at increased risk of fracture.
• Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures.
• Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.

The Prolia 60mg PFS Injection contains:

• Active ingredient: Denosumab 60 mg (60 mg/mL).
• Excipients: Acetic acid, glacial, sodium hydroxide, sorbitol (E420), polysorbate 20, and water for injections.

Dosage and Administration

1. The recommended dose of Prolia is 60 mg, administered as a single subcutaneous injection once every 6 months.
2. This injection should be given by a healthcare professional in the upper arm, upper thigh, or abdomen.
3. Patients must receive 1000 mg of calcium daily and at least 400 IU of vitamin D daily while on treatment.
4. If a dose is missed, administer the injection as soon as possible. Subsequent injections should then be scheduled every 6 months from the date of the last injection.
5. Allow the pre-filled syringe to reach room temperature (up to 25°C) for 15 to 30 minutes before use. Do not shake the syringe.

Storage and Disposal

• Store Prolia in a refrigerator between 2°C to 8°C (36°F to 46°F) in its original carton to protect it from light.
• Do not freeze the injection.
• Once removed from refrigeration, Prolia may be stored at room temperature (up to 25°C/77°F) for a maximum of 14 days in the original carton. It must be used within this period or discarded.
• Dispose of used pre-filled syringes immediately in an FDA-cleared sharps disposal container.
• Keep Prolia and all medicines out of the reach of children.

Precautions and Safety

• Pre-existing low blood calcium levels (hypocalcemia) must be corrected before starting Prolia treatment.
• Patients receiving Prolia should not be treated with other denosumab-containing products, such as Xgeva, at the same time.
• Serious infections, including skin infections like cellulitis, may occur. Seek immediate medical attention if you develop symptoms such as a swollen, red, hot, or tender area of skin, especially with fever.
• Osteonecrosis of the jaw (ONJ) has been reported. A dental examination is recommended before treatment, and maintaining good oral hygiene is important during therapy.
• Atypical femoral fractures have been reported. Report any new or unusual pain in your thigh, hip, or groin to your doctor.
• Multiple vertebral fractures have been reported after stopping Prolia. Do not stop, skip, or delay treatment without consulting your doctor.
• Serious allergic reactions, including anaphylaxis, can occur. Seek emergency medical help immediately if you experience trouble breathing, throat tightness, swelling of your face, lips, or tongue, rash, itching, or hives.
• Use with caution in patients with severe kidney problems, including those on dialysis, due to an increased risk of severe hypocalcemia.
• Pregnancy must be ruled out before starting Prolia. Use effective birth control during treatment and for at least 5 months after the last dose, as Prolia may harm an unborn baby.
• It is not known if Prolia passes into breast milk. Discuss with your doctor whether to stop breastfeeding or stop taking Prolia.

Side Effects and Risks

• Very common side effects include bone, joint, and/or muscle pain, which can sometimes be severe, and pain in the arms or legs.
• Common side effects may include headache, constipation, rash, urinary tract infection (painful or frequent urination), upper respiratory tract infection, sciatica (pain, tingling, or numbness down the leg), eczema, hair loss, abdominal discomfort, increased blood pressure, and high cholesterol.
• Uncommon side effects include diverticulitis (fever, vomiting, and abdominal pain or discomfort), ear infection, lichenoid drug eruptions, and injection site reactions.

Disclaimer

Use this medicine only under the prescription and guidance of a qualified doctor or pharmacist.