Pomahope 3mg (Pomalidomide)

DESCRIPTION

Pomalidomide is sold under the brand name Pomahope and it belongs to anti neoplastics drugs

Pomahope is doable as orally bioavailable thalidomide derivative asssociated with numerous therapeutic activities such as: immune modulatory, anti-angiogenesis, anti neoplastic. Pomahope combination with dexamethasone will cause liver injury

INDICATION

The primary indication of Pomahope is used in the treatment of Multiple Myeloma condition. In this condition, Pomahope is used by combining with dexamethasone. Pomahope capsules are applicable in; Previously the Patients treated with two treatment such as proteasome inhibitor & Lenalidomide. Patients who are suffered with disease progression condition Pomahope treatment should be followed within 60 days in patients who are concluded the last treatment.

MECHANISM OF ACTION

Pomahope 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.

ADME PROPERTIES

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.

DOSAGE MANAGEMENT

DURING MULTIPLE MYELOMA MALIGNANCIES

The dosage recommendation of Pomahope is 4mg should be administered as a single dose for 1 to 21 days of successive 28 day cycles. Pomahope 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: Pomahope treatment should be postponed and check the CBC weekly. ANC ≥ 500/mcL: Pomahope therapy should be continued by 3mg/day For each successive drop <500/mcL: Pomahope should be postponed. ANC ≥ 500/mcL: Continue the Pomahope therapy with 1mg/day.

THROMBOCYTOPENIA

Platelets count <25000/mcL: Pomahope therapy should be postponed and check CBC Platelets count ≥50000/mcL: 3mg of Pomahope should be taken daily

WITH STRONG CYP1A2

Pomahope 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 Pomahope 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.

PRECAUTION

EMBRYO FETAL DAMAGE

Pomahope should be contraindicated to pregnancy causes Teratogenecity, organogenesis and causes fetal damage. Avoid becoming pregnant during Pomahope therapy by using effective contraceptives.

VENOUS & ARTERIAL THROMBOEMBOLISM

Deep vein thrombosis is risk condition occurs during the Pomahope 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.

HEMATOLOGICAL TOXICITY

Neutropenia, thrombocytopenia is most common adverse effects occur during the Pomahope treatment. These may negate by checking the blood counts frequently and postponement of dosage or adjustment of dose is necessary.

LIVER TOXICITY

During Pomahope treatment, there is a chance of elevation of hepatic enzymes occurs. This may results as increased liver toxicity.

NEUROPATHY

Pomahope 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; Pomahope receiving patients has high chances of getting second primary malignancies.

TUMOR LYSIS SYNDROME

This condition is majorly occurred in Pomahope receiving patients. Monitor the manifestation due to this condition Appropriate management should be provided

SIDE EFFECTS

Common side effects

Asthenia, pain, back pain, headache, abdominal pain, infection, injury, flu like syndrome, chest pain, neoplasm, cystitis

Cardiovascular

Vasodilatation, hypertension

Digestive

Nausea, constipation, diarrhea, dyspepsia, GI disorders

Blood related effects

Lymph edema, anemia

Metabolism

Peripheral edema, weight gain, hypercholesterolemia  

Musculoskeletal

Arthritis, arthralgia, osteoporosis, fracture, bone pain, arthrosis, joint pain, Myalgia

Nervous

Depression, insomnia, dizziness, anxiety, paresthesia

Respiratory

Pharyngitis, cough increased, dyspnea, sinusitis, bronchitis

Skin

Rashes, sweating

Eye

Cataract specified

Urogenital

urinary tract infection, breast pain, breast neoplasm, vulvovaginitis, vaginal hemorrhage, vaginitis ; Leucorrhea

DRUG INTERACTION

Pomahope concurrently used with CYP1A2 drugs causes increased concentration of Pomalidomide. Overcome this problem by reducing the dose of Pomahope during this combination therapy.

CONTRAINDICATION

Pomahope is contraindicated to; Pregnancy Lactation Hypersensitivity reactions produced due to patients are contraindicated to the component of Pomahope .

PREGNANCY & LACTATION

Pregnancy category of Pomahope is X Pomahope usage during pregnancy period, leads to fetal harm and causes death. Breast feeding should not be recommended.

STORAGE

The Pomahope capsules container should be stored at 20°C to 25°C Protect the container from moisture, heat, & light.

MISSED DOSE

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.