Pomyelo 1mg (Pomalidomide)
Pomalidomide is sold under the brand name Pomyelo and it belongs to anti neoplastics drugs
Pomyelo is doable as orally bioavailable thalidomide derivative asssociated with numerous therapeutic activities such as: immune modulatory, anti-angiogenesis, anti neoplastic. Pomyelo combination with dexamethasone will cause liver injury
The primary indication of Pomyelo is used in the treatment of Multiple Myeloma condition. In this condition, Pomyelo is used by combining with dexamethasone. Pomyelo capsules are applicable in; Previously the Patients treated with two treatment such as proteasome inhibitor & Lenalidomide. Patients who are suffered with disease progression condition Pomyelo treatment should be followed within 60 days in patients who are concluded the last treatment.
MECHANISM OF ACTION
Pomyelo has three primary pharmacological activities against cancer cells. Pomalidomide includes in the way cancer proliferation and provoke the apoptosis of cancer cells. Pomalidomide enhance the T cell & natural killer cells interceding immunity & inhibits the formation of pro inflammatory cytokines from monocytes. Pomalidomide forbid the new cell formation. The binding of Pomalidomide to active site of targeted cell causes inhibition of ubiquitin ligase action.
The time to high serum concentration of Pomalidomide is reaches between 2 to 3 hours. It should be administered with or without food. Hence No effect of food should be produced; Volume of distribution of Pomalidomide is between 62 & 138L in steady state.
The Pomalidomide distribution by 67% of serum level at after 4 hours of drug intake. human plasma protein by bounding range of 12% & 44%. Hepatically mediated through CYP1A2, CYP3A4 is Pomalidomide is metabolized.
Pomalidomide clearance value is 7 to 10L/hr. Doses are excreted via urine 73% & feces 15% respectively. Doses are excreted as an unchanged form via urine 2% & feces 8%. Pomalidomide half life period is 9.5 hours.
DURING MULTIPLE MYELOMA MALIGNANCIES
The dosage recommendation of Pomyelo is 4mg should be administered as a single dose for 1 to 21 days of successive 28 day cycles. Pomyelo is combined with dexamethasone with low dose. Administrate Dexamethasone on day 1, 8, 15 & 22 of each 28 day cycle. The prescribed dose of dexamethasone is 40mg should be administered the patient having weight about ≤ 75kg. The prescribed dose of dexamethasone is 20mg given for patient’s weight Greater than 75kg
DOSAGE ALTERATION DURING HEMATOLOGICAL TOXICITIES NEUTROPENIA
ANC <500/mcL: Pomyelo treatment should be postponed and check the CBC weekly. ANC ≥ 500/mcL: Pomyelo therapy should be continued by 3mg/day For each successive drop <500/mcL: Pomyelo should be postponed. ANC ≥ 500/mcL: Continue the Pomyelo therapy with 1mg/day.
Platelets count <25000/mcL: Pomyelo therapy should be postponed and check CBC Platelets count ≥50000/mcL: 3mg of Pomyelo should be taken daily
WITH STRONG CYP1A2
Pomyelo combined with CYP1A2 substrates causes increasing the plasma concentration of Pomalidomide and leads to elevate the risk of Pomalidomide.
IN RENAL DAMAGED PATIENTS
In severe renal impaired patients, the suggested dose of Pomyelo is 3mg per day.
IN HEPATIC IMPAIRED PATIENTS
The advised dose is 3mg/day & in severe condition, the suggested dose is 2mg/day given for mild to moderate patients.
EMBRYO FETAL DAMAGE
Pomyelo should be contraindicated to pregnancy causes Teratogenecity, organogenesis and causes fetal damage. Avoid becoming pregnant during Pomyelo therapy by using effective contraceptives.
VENOUS & ARTERIAL THROMBOEMBOLISM
Deep vein thrombosis is risk condition occurs during the Pomyelo treatment. Thromboprophylaxis is initiated for this condition. In case of pembrolizumab given to thalidomide & dexamethasone causes Elevation of mortality Pembrolizumab combined with dexamethasone causes mortality in high range in multiple myeloma condition. The combination of PD-1 or PD-L1 blocking agent with thalidomide analogue with dexamethasone has not evaluated.
Neutropenia, thrombocytopenia is most common adverse effects occur during the Pomyelo treatment. These may negate by checking the blood counts frequently and postponement of dosage or adjustment of dose is necessary.
During Pomyelo treatment, there is a chance of elevation of hepatic enzymes occurs. This may results as increased liver toxicity.
Pomyelo combined with low dose of dexamethasone causes peripheral neuropathy in some patients. Prevent the treatment until toxicity grade chances to 1 or 0 Exposure of second primary malignancies; Pomyelo receiving patients has high chances of getting second primary malignancies.
TUMOR LYSIS SYNDROME
This condition is majorly occurred in Pomyelo receiving patients. Monitor the manifestation due to this condition Appropriate management should be provided
Common side effects
Asthenia, pain, back pain, headache, abdominal pain, infection, injury, flu like syndrome, chest pain, neoplasm, cystitis
Nausea, constipation, diarrhea, dyspepsia, GI disorders
Blood related effects
Lymph edema, anemia
Peripheral edema, weight gain, hypercholesterolemia
Arthritis, arthralgia, osteoporosis, fracture, bone pain, arthrosis, joint pain, Myalgia
Depression, insomnia, dizziness, anxiety, paresthesia
Pharyngitis, cough increased, dyspnea, sinusitis, bronchitis
urinary tract infection, breast pain, breast neoplasm, vulvovaginitis, vaginal hemorrhage, vaginitis ; Leucorrhea
Pomyelo concurrently used with CYP1A2 drugs causes increased concentration of Pomalidomide. Overcome this problem by reducing the dose of Pomyelo during this combination therapy.
Pomyelo is contraindicated to; Pregnancy Lactation Hypersensitivity reactions produced due to patients are contraindicated to the component of Pomyelo .
PREGNANCY & LACTATION
Pregnancy category of Pomyelo is X Pomyelo usage during pregnancy period, leads to fetal harm and causes death. Breast feeding should not be recommended.
The Pomyelo capsules container should be stored at 20°C to 25°C Protect the container from moisture, heat, & light.
Missed dose occurred during the therapy should be taken into consideration. Missed dose leads to over dosage condition. In case missed dose occurs, consult with physician & follow the regular dsoing schedule.