| Dossier: | Ctd |
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| Transport Package: | Free |
| Specification: | 3.5mg |
| Trademark: | Sinolead |
| Origin: | China |
| Samples: |
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| Customization: |
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| Generic Name | Bortezomib for Injection 3.5mg |
| Strength | 3.5mg |
| Packing | 1vial/box |
| Origin | China |
This product is white or white like mass or powder.
This product is indicated for the treatment of patients with multiple myeloma who have received at least two treatments prior to the use of this product and whose disease is progressing at the time of the most recent treatment.
This product is indicated for the treatment of patients with relapsed or refractory mantle cell lymphoma who have received at least one treatment prior to use of this product. Safety and efficacy data for this indication were obtained from a foreign single-arm Phase II clinical study in mantle cell lymphoma that relapsed after prior treatment (see Clinical Trials)
Usage and dosage:
Grown man
Recommended dose for monotherapy
The recommended dose is 1.3 mg/m2 in a single injection twice a week for 2 weeks (i.e., on days 1, 4, 8 and 11) followed by 10 days of discontinuation (i.e., from days 12 to 21).
3 weeks is a course of treatment, two dosing at least 72 hours apart.
Maintenance therapy for more than eight courses may be administered as a standard regimen or as a maintenance regimen once a week for four weeks (days 1, 8, 15, and 22) followed by a 13-day rest period (days 23 to 25).
Dose adjustment and re-initiation of treatment
When grade 3 non-hematologic toxicity or any grade 4 hematologic toxicity (excluding neuropathy as discussed below) occurs, treatment should be discontinued. Once the toxic symptoms have resolved, treatment with this product can be resumed with a dose reduction of 25% (e.g., 1.3mg/m2 to 1.0mg/m2; 1.0mg/m2 reduced to 0.7mg/m2). If the patient develops neuralgia or peripheral sensory neuropathy related to the treatment of this product, the adjusted dose recommended in the table below should be treated. If the patient has severe neuropathy, use this product only after weighing the benefits and risks.
Table 1: Recommended dose adjustments for neuralgia or peripheral sensory neuropathy associated with the treatment of this product
The severity of the symptoms and signs of peripheral neuropathy was adjusted
Grade 1 (paresthesia or loss of reflexes), not accompanied by no change
Pain or loss of function
Grade 1, with pain or grade 2 (dysfunction, but without dose reduction to 1.0mg/m2
Affect daily life)
Grade 2, accompanied by pain or grade 3 (affecting daily life) suspend the treatment of this product until the treatment of this product is resumed after the relief of toxic symptoms.
The dose was reduced to 0.7mg/m2 and changed to once a week.
Grade 4 (permanent sensory loss, dysfunction) discontinuation of treatment with this product.
Matters needing attention:
Use should be under the supervision of a physician experienced in the use of antitumor drugs, and complete blood count (CBC) should be monitored frequently during the use of this product. This product is an anti-tumor drug, should be prepared carefully, wear gloves to prevent skin contact.
Overall, the safety profile of this monotherapy was similar to that observed in combination with mepharan and prednisone.
· Peripheral neuropathy
Treatment with this product may result in peripheral neuropathy, mainly on the sensory nerves, although sensorimotor neuropathy has been rarely reported. Patients with preexisting symptoms of peripheral neuropathy (numbness, pain, or burning in the feet or hands) or signs of peripheral neuropathy may have increased symptoms of neuropathy (including grade ≥3) during treatment with this product. It is recommended to monitor such patients for symptoms of neuropathy, such as burning, hyperesthesia, hypoesthesia, paresthesia, discomfort, or neuralgia. If patients develop new peripheral neuropathy or their symptoms worsen, the dose and treatment regimen of this product may need to be adjusted. In a single-dose Phase III trial, 51% of patients with grade 2 and above reported improvement or disappearance of peripheral neuropathy as the dose was adjusted. In a Phase II trial of multiple myeloma, 73% of patients who dropped out due to grade 2 neuropathy or had grade 3 and above peripheral neuropathy reported improvement or disappearance of peripheral neuropathy. Long-term outcomes of peripheral neuropathy have not been studied in mantle cell lymphoma.
· Hypotension
In Phase II and III trials of monotherapy for multiple myeloma, the incidence of hypotension (orthostatic or postural and unspecified hypotension) was 11 to 12 percent. This phenomenon was observed throughout the course of treatment. Caution is recommended if the patient has a known history of syncope, if the patient is taking medications that can cause hypotension, or if the patient is dehydrated. Orthostatic or postural hypotension can be treated by adjusting antihypertensive medications, rehydration, or the use of salt corticosteroids and/or sympathomimetic drugs.
· Heart disease
There were reports of acute congestive heart failure or worsening, and/or decreased left ventricular ejection fraction, including those with no or very low risk of reduced left ventricular ejection fraction. Patients at risk or those with heart disease should be closely monitored. In a Phase III trial of monotherapy for multiple myeloma, the incidence of sudden heart disease was 15% in the bortezomib group and 13% in the dexamethasone group. The incidence of heart failure (acute pulmonary edema, heart failure, congestive heart failure, cardiogenic shock, pulmonary edema) was similar in the two groups, 5% and 4%, respectively. There have been isolated cases of QT interval prolongation, but no causal relationship has been established.
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