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pomide

Brand: 印度HETERO
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Pomalidomide Instructions
Common name: Pomalidomide
Trade name: Pomalyst
All names: Pomalidomide, Pomalidomide capsules, Pomalid, Pomalidomide, Pomalyst, lmnovid


Indications:
Applicable to patients with multiple myeloma who have received at least two prior treatments including lenalidomide and bortezomib, who have not responded to the treatment (failed to respond) and who have progressed within 60 days of the last treatment (relapsed and refractory).


Usage and dosage:
On days 1 to 21, give 4 mg of pomalidomide; on days 1, 8, 15 and 22, give 40 mg of low-dose dexamethasone (20 mg for patients over 75 years old), and treat until the patient's disease progresses or intolerable toxicity.


Adverse reactions:
> 10%
Fatigue and weakness (55-63%)
Neutropenia (47-52%)
Dyspnea (34-45%)
Anemia (38-39%)
Constipation (35-36%)
Nausea (22-36%)
Diarrhea (33-34%)
Back pain (30-32%)
Upper respiratory tract infection (25-32%)
Fever (19-30%)
Pneumonia (23-29%)
Thrombocytopenia (23-25%)
Peripheral edema (16-23%)Musculoskeletal chest pain (20-22%)
Decreased appetite (18-22%)
Skin rash (16-22%)
Cough (14-21%)
Hypercalcemia (12-21%)
Dizziness (17-20%)
Muscle cramps (19%)
br>Leukopenia (11-18%)
Arthralgia (15-16%)
Urinary tract infection (8-16%)
Hyperhidrosis (6-16%)
Hyperglycemia (12-15%)
Musculoskeletal pain (11-15%)
Epistaxis (11 -15%)
Pruritus (11-15%)
Increased serum creatinine (11-15%)
Renal failure (10-15%)
Lymphopenia (4-15%)
Vomiting (13-14%)
Weight loss (8-14%)
Loss Insomnia (7-14%)
Extremity pain (5-14%)
Hyponatremia (10-13%)
Confusion (10-13%)
Tremor (9-13%)
Headache (8-13%)
Night sweats (5-13%)
Muscle weakness (1 2%)
Hypocalcemia (6-12%)
Bone pain (5-12%)
Hypokalemia (11%)
Dry skin (9-11%)
Shivers (9-11%)
Anxiety (7-11%)
Weight gain (1-11%)


1-10%
Neuropathy, peripheral (7-10%)
Pain (5-6%)
Thromboembolism (3%)
Febrile neutropenia (3%)


Contraindications:

Pregnancy. Pomalidomide can cause fetal damage and is contraindicated in pregnant women.


Notes:
(1) Hematological toxicity: Neutropenia is the most commonly reported grade 3/4 adverse event. Monitor patients for hematologic toxicity, especially neutropenia.
(2) Liver: liver failure and death; monitor liver function tests once a month.
(3) Allergic reactions: angioedema and severe dermatological reactions. Discontinue POMALYST for angioedema and severe dermatologic reactions.
(4) Tumor lysis syndrome (TLS): Monitor patients at risk for TLS (i.e., those with high tumor burden) and take appropriate preventive measures.


Storage:
Sealed


Mechanism of action:
Pomalidomide, a thalidomide analog, is an immunomodulator with anti-tumor activity. In in vitro cytology assays, pomalidomide inhibits hematopoietic tumor cell proliferation and induces apoptosis. Furthermore, pomalidomide inhibits the proliferation of lenalidomide-resistant, multiple myeloma cell lines and synergizes with dexamethasone to induce tumor cell apoptosis in both lenalidomide-sensitive and lenalidomide-resistant cell lines. Pomalidomide enhances T cell and natural killer (NK) cell-mediated immunity and inhibits the production of proinflammatory cytokines (eg, TNF-α and IL-6) by monocytes. Pomalidomide exhibits anti-angiogenic activity in mouse tumor models and in vitro umbilical cord models.


Efficacy and safety:
A total of 682 RRMM patients were included in this study, with a median age of 66 years and a median time of 5.3 years since diagnosis. The median number of prior treatments received was 5. Median follow-up was 16.8 months; median treatment duration was 4.9 months. The most common grade 3/4 treatment-emergent adverse reactions were hematologic toxicities (neutropenia [49.7%], anemia [33%], and thrombocytopenia [24.1%]). The most common grade 3/4 non-hematologic toxic events were pneumonia (10.9%) and fatigue (5.9%). Grade 3/4 venous thromboembolism and peripheral neuropathy were less common (1.6% each). The ORR was 32.6%, and the median DOR was 7.4 months. Median PFS and OS were 4.6 months and 11.9 months, respectively.