Xgeva Injection 120mg Imported In Pakistan
Xgeva Injection Overview
Xgeva (Denosumab) is a medication used primarily for:
- Prevention of skeletal-related events in adults with advanced malignancies involving bone.
- Treatment of unresectable giant cell tumors of bone in adults and skeletally mature adolescents.
Availability in Pakistan
- Formulation: Xgeva Injection 120 mg
- Import Status: Imported
- Price Range: Approximately Rs. 35,000 to Rs. 45,000 per vial (prices may vary based on the pharmacy).
Administration Guidelines
Dosage
- Standard Dose: 120 mg administered as a single subcutaneous injection.
- Frequency: Once every four weeks.
- Special Consideration: For patients with giant cell tumors, additional doses may be required during the first month.
Storage Instructions
- Refrigeration: Store between 2°C – 8°C.
- Room Temperature: Can be kept at room temperature (up to 25°C) for up to 30 days once removed from refrigeration.
- Freezing: Do not freeze.
Supplementation Requirements
Patients should receive supplementation of:
- Calcium: At least 500 mg daily.
- Vitamin D: At least 400 IU daily (unless contraindicated).
Monitoring and Administration
- Healthcare Supervision: Xgeva should be administered under the supervision of a healthcare professional.
- Regular Monitoring: Patients should be monitored for treatment efficacy and potential side effects.
Original price was: ₨30,000.00.₨25,000.00Current price is: ₨25,000.00.
Description
Xgeva Injection Overview
Xgeva (Denosumab) is a medication used primarily for:
- Prevention of skeletal-related events in adults with advanced malignancies involving bone.
- Treatment of unresectable giant cell tumors of bone in adults and skeletally mature adolescents.
Availability in Pakistan
- Formulation: Xgeva Injection 120 mg
- Import Status: Imported
- Price Range: Approximately Rs. 35,000 to Rs. 45,000 per vial (prices may vary based on the pharmacy).
Administration Guidelines
Dosage
- Standard Dose: 120 mg administered as a single subcutaneous injection.
- Frequency: Once every four weeks.
- Special Consideration: For patients with giant cell tumors, additional doses may be required during the first month.
Storage Instructions
- Refrigeration: Store between 2°C – 8°C.
- Room Temperature: Can be kept at room temperature (up to 25°C) for up to 30 days once removed from refrigeration.
- Freezing: Do not freeze.
Supplementation Requirements
Patients should receive supplementation of:
- Calcium: At least 500 mg daily.
- Vitamin D: At least 400 IU daily (unless contraindicated).
Monitoring and Administration
- Healthcare Supervision: Xgeva should be administered under the supervision of a healthcare professional.
- Regular Monitoring: Patients should be monitored for treatment efficacy and potential side effects.
Key Benefits of Xgeva
- Prevention of Skeletal-Related Events: Xgeva is effective in preventing skeletal-related events (SREs) such as pathological fractures, radiation therapy to bone, spinal cord compression, and surgeries related to bone in patients with advanced malignancies involving bone.
- Treatment of Giant Cell Tumors: It is indicated for the treatment of adults and skeletally mature adolescents with unresectable giant cell tumors of bone, or where surgical resection may lead to severe morbidity.
- Reduction of High Calcium Levels: Xgeva helps lower elevated blood calcium levels (hypercalcemia) caused by malignancies, particularly when other treatments have failed.
- Bone Density Improvement: By inhibiting osteoclast formation and function, Xgeva decreases bone breakdown, which can improve bone density and strength.
- Convenient Administration: The injection is administered subcutaneously once every four weeks, allowing for a straightforward treatment regimen.
Key Ingredients in Xgeva
- Active Ingredient:
- Denosumab: A human monoclonal IgG2 antibody that specifically binds to RANKL (Receptor Activator of Nuclear Factor Kappa-Β Ligand), inhibiting osteoclast formation, function, and survival, thereby reducing bone resorption.
- Excipient Ingredients:
- Sorbitol: 78 mg per 1.7 mL solution, used as a stabilizer.
- Acetate: 18 mM, used to maintain pH.
- Polysorbate 20: 0.01%, an emulsifier.
- Water for Injection: The solvent used in the formulation.
- Sodium Hydroxide: Used to adjust the pH to 5.2.
Mechanism of Action
Xgeva (denosumab) is a human IgG2 monoclonal antibody that binds to human RANKL (Receptor Activator of Nuclear Factor Kappa-Β Ligand), a transmembrane or soluble protein essential for the formation, function, and survival of osteoclasts, the cells responsible for bone resorption.Xgeva prevents RANKL from activating its receptor, RANK, on the surface of osteoclasts and their precursors. This inhibition decreases the differentiation, activity, and survival of osteoclasts, thereby reducing bone resorption and the risk of skeletal-related events (SREs) in patients with bone metastases from solid tumors.In giant cell tumors of bone, the tumor consists of stromal cells expressing RANKL and osteoclast-like giant cells expressing RANK receptor. Signaling through the RANK receptor contributes to osteolysis and tumor growth. By preventing RANKL from activating RANK, Xgeva inhibits this process and is effective in treating giant cell tumors of bone.
DenosumabHuman monoclonal antibody used for the treatment of various bone conditionsMoreUsesTreatment of osteoporosis, treatment-induced bone loss, bone metastases, and giant cell tumor of boneContraindicationsNot to be used by individuals with low blood calcium levelsCommon Side EffectsJoint and muscle pain, increased risk of infections, hypocalcemiaXgeva (denosumab) is a fully human IgG2 monoclonal antibody with high affinity and specificity for human RANK Ligand (RANKL). Denosumab has an approximate molecular weight of 147 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells.Denosumab is not a small molecule drug, so it does not have a typical chemical structure like a synthetic drug. As a monoclonal antibody, its structure consists of four polypeptide chains – two identical heavy chains and two identical light chains – linked together by disulfide bonds.Denosumab, the active ingredient in Xgeva injection, is a fully human IgG2 monoclonal antibody produced in genetically engineered Chinese Hamster Ovary (CHO) cells using recombinant DNA technology. The key steps in the synthesis of denosumab are:Cell Line Development
- Transfection of CHO cells with DNA encoding the heavy and light chains of the denosumab antibody
- Selection and characterization of a high-producing, stable cell line
Cell Culture and Purification
- Cultivation of the CHO cells in bioreactors to produce denosumab
- Purification of denosumab from the cell culture medium using a series of chromatography steps (protein A, cation exchange, hydrophobic interaction) and viral inactivation
Formulation and Packaging
- Dilution of the purified denosumab to the desired concentration (60 mg/mL) using a formulation buffer containing acetate and sorbitol
- Filling into vials, pre-filled syringes or auto-injectors under aseptic conditions
- Packaging, labeling and shipping of the final drug product
Key Precautions for Xgeva
- Allergic Reactions: Patients should inform their healthcare provider if they have a history of allergies to denosumab or any components of Xgeva. Signs of serious allergic reactions include rash, itching, swelling, and difficulty breathing.
- Hypocalcemia: Xgeva should not be administered to individuals with low calcium levels in the blood (hypocalcemia). It is essential to correct hypocalcemia before starting treatment.
- Osteonecrosis of the Jaw (ONJ): There is a risk of ONJ, particularly in patients with cancer, those receiving chemotherapy, radiation, or steroids, and individuals with dental issues. Patients should maintain good dental hygiene and inform their dentist about their treatment with Xgeva.
- Pregnancy and Breastfeeding: Denosumab can harm an unborn baby. Women of childbearing potential must use effective contraception during treatment and for at least five months after the last dose. Breastfeeding is not recommended while using Xgeva.
- Kidney Disease: Patients with kidney disease or those on dialysis should discuss their condition with their doctor before receiving Xgeva, as it may affect treatment safety.
- Infection Risk: Xgeva may increase the risk of infections. Patients should avoid close contact with individuals who are sick and report any signs of infection to their healthcare provider.
- Monitoring: Regular monitoring through blood tests may be necessary to check for unwanted effects, including calcium levels and signs of bone loss.
Dietary Restrictions
- Calcium and Vitamin D: While receiving Xgeva, patients are often prescribed calcium and vitamin D supplements to prevent or treat low calcium levels. It is crucial to take only the amounts prescribed by the healthcare provider.
- Hydration: Staying well-hydrated is important, especially for patients with kidney issues.
- Avoiding Certain Foods: There are no specific dietary restrictions for Xgeva; however, patients should maintain a balanced diet to support overall health and bone strength.
Drug Interactions
- Total Interactions: There are 284 drugs known to interact with Xgeva, including:
- 5 Major Interactions: These are drugs that should generally be avoided due to significant risks outweighing benefits.
- 279 Moderate Interactions: These may require special circumstances for use and should be monitored closely.
- Commonly Checked Interactions: Some frequently checked medications include:
- Prednisone
- Methotrexate
- Methylprednisolone
- Calcium/Vitamin D supplements
- Amlodipine
- Atorvastatin
- Dexamethasone
- Eliquis (apixaban)
- Gabapentin
- Letrozole
- Specific Considerations:
- Prolia: Patients should not use Prolia (another denosumab product) while receiving Xgeva.
- Calcium and Vitamin D: Supplementation is often prescribed to prevent hypocalcemia, but dosages should be monitored to avoid excessive intake.
Disease Interactions
Xgeva has 2 known disease interactions that may affect treatment decisions:
- Hypocalcemia: Patients with low calcium levels should not receive Xgeva until their calcium levels are corrected.
- Osteonecrosis of the Jaw (ONJ): Patients with a history of dental issues or those undergoing dental procedures should be monitored closely, as ONJ risk may increase.
Recommendations
- Consult Healthcare Providers: Patients should inform their healthcare providers about all medications they are taking, including over-the-counter drugs and supplements, to manage potential interactions effectively.
- Monitoring: Regular monitoring of calcium levels and dental health is recommended for those receiving Xgeva.
There are several medications that should be avoided or used with caution when taking Xgeva (denosumab):
Prolia
Patients receiving Xgeva should not take Prolia, another brand of denosumab, as both contain the same active ingredient. Taking both could lead to an increased risk of side effects and more severe side effects like hypercalcemia.
Bisphosphonates
Patients being treated with Xgeva should not be treated concomitantly with bisphosphonates.
Immunosuppressants
Taking Xgeva with immunosuppressants like corticosteroids (e.g. prednisone) or biologics can weaken the immune system and increase the risk of serious infections, especially if the immune system is already compromised. Talk to your doctor before using Xgeva if you are taking immunosuppressants.
Calcimimetics
Concomitant use of calcimimetics and other drugs that can lower calcium levels may worsen hypocalcemia risk with Xgeva. Serum calcium should be closely monitored.
Chemotherapy Agents
Certain chemotherapy agents like cyclophosphamide, methotrexate, or bleomycin may interact with Xgeva.
Pregnancy
- Xgeva can cause fetal harm when administered to a pregnant woman based on findings in animals.
- In utero exposure to denosumab in cynomolgus monkeys resulted in increased fetal loss, stillbirths, postnatal mortality, absent lymph nodes, abnormal bone growth, and decreased neonatal growth.
- There are insufficient data with denosumab use in pregnant women to inform any drug-associated risks for adverse developmental outcomes.
- Women of childbearing potential should be advised to use effective contraception during therapy and for at least 5 months after the last dose.
Breastfeeding
- It is not known whether denosumab is present in human milk, affects human milk production, or has effects on the breastfed child.
- In cynomolgus monkeys, denosumab was detected in maternal milk up to 1 month after the last dose (≤ 0.5% milk:serum ratio) and maternal mammary gland development was normal, with no impaired lactation.
- However, pregnant RANKL knockout mice showed altered maturation of the maternal mammary gland, leading to impaired lactation.
- The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Xgeva treatment and any potential adverse effects on the breastfed child.
Risks of Xgeva During Pregnancy
- In animal studies, exposure to Xgeva during pregnancy resulted in increased fetal loss, stillbirths, and postnatal mortality in cynomolgus monkeys.
- Offspring exposed to Xgeva in utero showed abnormal bone growth, reduced bone strength, absence of lymph nodes, dental issues, and decreased neonatal growth.
- There are no adequate and well-controlled studies of Xgeva use in pregnant women. The potential risks to the human fetus are unknown, but are expected to be significant based on animal data.
Recommendations
- Women should be advised not to become pregnant while taking Xgeva.
- If a patient becomes pregnant during Xgeva treatment, the potential risks and benefits of continuing or discontinuing treatment should be carefully considered.
- Pregnant women exposed to Xgeva are encouraged to enroll in Amgen’s Pregnancy Surveillance Program to monitor outcomes.
- Females of reproductive potential should use effective contraception during Xgeva therapy and for at least 5 months after the last dose.
Dosage of Xgeva
- Formulation: Xgeva is available as a solution for injection, with each vial containing 120 mg of denosumab in 1.7 mL of solution.
- Recommended Dosage:
- For multiple myeloma and bone metastasis from solid tumors: The standard dose is 120 mg subcutaneously once every 4 weeks.
- For giant cell tumors and hypercalcemia caused by cancer: Additional doses may be required on days 8 and 15 of the first month of therapy.
- Administration: Xgeva is administered by a healthcare professional via subcutaneous injection, typically in the upper arm, upper thigh, or abdomen.
Storage of Xgeva
- Refrigeration: Store Xgeva in a refrigerator at a temperature of 2°C to 8°C (36°F to 46°F) in the original carton to protect it from light.
- Room Temperature: Once removed from the refrigerator, Xgeva can be kept at room temperature (up to 25°C or 77°F) for up to 30 days. It must be used within this timeframe or discarded.
- Avoid Freezing: Do not freeze Xgeva. Protect it from direct light and heat, and avoid vigorous shaking.
User Reviews
- Overall Rating: Xgeva has received a user rating of 6.6 out of 10 based on 9 reviews.
- Feedback: Users have provided mixed feedback regarding the effectiveness and side effects of the medication, which is common with treatments for serious conditions like cancer.
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