Product
Anti-cancer Products (Zoldria)

Anti-cancer Products (Zoldria)
 
Zoldria
Zoldria Injection

COMPOSITION
Each vial contains Zoledronic acid monohydrate equivalent to Zoledronic acid anhydrous 4 mg as sterile freeze dried powder for reconstitution with 5ml of Sterile Water for Injection IP

Indications and Usage
Hypercalcemia of Malignancy - Zoldria (zoledronic acid) Injection is indicated for the treatment of hypercalcemia of malignancy.
Multiple Myeloma and Bone Metastases of Solid Tumors - Zoldria is indicated for the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy.

Dosage and Administration
Hypercalcemia of Malignancy
Consideration should be given to the severity of as well as the symptoms of tumor-induced hypercalcemia when considering use of Zoldria (zoledronic acid) Injection. Vigorous saline hydration alone may be sufficient to treat mild, asymptomatic hypercalcemia.
 

The maximum recommended dose of Zoldria in hypercalcemia of malignancy (albumin-corrected serum calcium* ≥ 12 mg/dL [3.0 mmol/L])
is 4 mg. The 4-mg dose must be given as a single-dose intravenous infusion over no less than 15 minutes.
Patients should be adequately rehydrated prior to administration of Zoldria. (See Warnings and Precautions). Retreatment with Zoldria 4 mg may be considered if serum calcium does not return to normal or remain normal after initial treatment. It is recommended that a minimum of 7 days elapse before retreatment, to allow for full response to the initial dose. Renal function must be carefully monitored in all patients receiving Zoldria and possible deterioration in renal function must be assessed prior to treatment with Zoldria. (See Warnings and Precautions).
* Albumin-corrected serum calcium (Cca, mg/dL) = Ca + 0.8 (mid-range albumin-measured albumin in mg/dL).
Multiple Myeloma and Metastatic Bone Lesions From Solid Tumors The recommended dose of Zoldria in patients with multiple myeloma and metastatic bone lesions from solid tumors is 4 mg infused over 15 minutes every three or four weeks. Duration of treatment in the clinical studies was 15 months for prostate cancer, 12 months for breast cancer and multiple myeloma, and 9 months for other solid tumors. Patients should also be administered an oral calcium supplement of 500 mg and a multiple vitamin containing 400 IU of Vitamin D daily.
Serum creatinine should be measured before each Zoldria dose and treatment should be withheld for renal deterioration. In the clinical studies, renal deterioration was defined as follows:
• For patients with normal baseline creatinine, increase of 0.5 mg/dL
• For patients with abnormal baseline creatinine, increase of 1.0 mg/dL
In the clinical studies, Zoldria treatment was resumed only when the creatinine returned to within 10% of the baseline value.

Preparation of the solution
Vials of Zoldria concentrate for infusion contain overfill allowing for the withdrawal of 5 mL of concentrate (equivalent to 4 mg zoledronic acid). This concentrate should immediately be diluted in 100 mL of sterile 0.9% of Sodium Chloride, USP, or 5% Dextrose Injection, USP. Do not store undiluted concentrate in a syringe, to avoid inadvertent injection. The dose must be given as a single intravenous infusion over no less than 15 minutes.
If not used immediately after dilution with infusion media, for microbiological integrity, the solution should be refrigerated at 2 o C - 8 o C (36 o F- 46 o F). The refrigerated solution should then be equilibrated to room temperature prior to administration. The total time between dilution, storage in the refrigerator, and end of administration must not exceed 24 hours. Zoldria must not be mixed with calcium-containing infusion solutions, such as Lactated Ringer’s solution, and should be administered as a single intravenous solution in a line separate from all other drugs

Method of administration
Due to the risk of clinically significant deterioration in renal function, which may progress to renal failure, single doses of Zoldria should not exceed 4 mg and the duration of infusion should be no less than 15 minutes (See Warnings). There must be strict adherence to the intravenous administration recommendations for Zoldria in order to decrease the risk of deterioration in renal function.
Note: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Contraindications
Zoldria injection is contraindicated in patients with clinically significant hypersensitivity to zoledronic acid or other bisphosphonates, or any of the excipients in the formulations of Zoldria.

Presentation
Zoldria Vial of 10 ml

zoldria注射液

组成
每小瓶含无菌冷冻干燥的重组粉与无菌水5毫升的IP注射无水4毫克唑来膦酸水合物相当于唑来膦酸

适应症和用途
被用于治疗恶性高钙血症高钙血症恶性肿瘤 - Zoldria的（唑来膦酸）注射。
固体肿瘤的多发性骨髓瘤和骨转移 - Zoldria用于治疗多发性骨髓瘤和记录从实体瘤骨转移的患者，在与标准的抗肿瘤治疗，患者表示。应该有进展后，至少有一个荷尔蒙疗法治疗前列腺癌。

剂量和给药方法
高钙血症的恶性肿瘤
应考虑到的严重程度，以及肿瘤引起的高钙血症考虑使用的Zoldria（唑来膦酸）注射时的症状。大力盐水水化单独可能不足以治疗轻度的，无症状的高钙血症。

最大推荐剂量的恶性高钙血症（白蛋白校正血清钙≥12毫克/升3.0毫摩尔/升）Zoldria
4毫克。必须给予不低于15分钟，作为一个单剂量静脉滴注4毫克剂量。
患者应充分水化前Zoldria管理。 （见警告和注意事项）。可考虑复用Zoldria 4毫克，如果血钙不会恢复到正常或初步治疗后保持正常。据建议，经过至少7天前复，以便充分反应的初始剂量。在所有患者接收Zoldria和可能必须治疗与Zoldria前进行评估肾功能的恶化，肾功能，必须仔细监测。 （见警告和注意事项）。
*白蛋白校正血钙（CCA，毫克/升）= CA + 0.8（毫克/升的中档白蛋白计量白蛋白）。
多发性骨髓瘤和从实体瘤骨转移病变的多发性骨髓瘤和实体瘤骨转移病变患者的Zoldria建议剂量是4毫克注入超过15分钟，每三，四个星期。前列腺癌，乳腺癌和多发性骨髓瘤12个月，9个月的其他实体瘤治疗的临床研究时间为15个月。患者也应给予口服500毫克及多种维生素，含400 IU维生素D每天补充钙。
应测定血清肌酐前每个Zoldria剂量和治疗肾功能恶化应扣缴。在临床研究中，肾功能恶化的定义如下：
•对于患者与正常基线肌酐，增加0.5毫克/升
•基线肌酐异常的患者，增加1.0毫克/升
在临床研究，Zoldria治疗恢复，只有当的肌酐返回内基准值的10％。

溶液的制备
Zoldria样品瓶集中输液包含溢出，允许撤回5毫升浓缩（相当于4毫克唑来膦酸）。这应立即稀释浓缩在100毫升无菌氯化钠0.9％，美国药典，或5％葡萄糖注射液，USP。不要储存在注射器稀释的浓缩液，以避免无意的注射。必须给予不低于15分钟，作为一个单一的静脉滴注的剂量。
如果不立即与输液媒体稀释后使用，微生物完整的解决方案应该是冷藏在2℃ - 8℃（36 O架F-46华氏度）。然后冷藏解决方案应该是平衡到室温前管理。稀释，存放在冰箱，结束和管理之间的总时间不得超过24小时。 zoldria必须不能与含钙输液的解决方案，如乳酸林格氏液，混合，行独立于所有其他药物，应作为一个单一的输液管理

管理方法
由于肾功能的恶化，可能发展为肾功能衰竭的临床显着的风险，单Zoldria的剂量不应超过4毫克和输液时间应不小于15分钟（见警告）。必须严格遵守，以静脉给药为Zoldria的建议，以减少肾功能恶化的危险。
注：视觉的颗粒物质和变色，只要溶液及容器许可管理之前，应检查注射药物产品。

禁忌
zoldria注射禁忌在临床上显着的唑来膦酸或其他双膦酸盐，或对在配方Zoldria的任何赋形剂过敏的患者。

介绍
10毫升的zoldria瓶