Pomalidomide (Pomalyst) is a derivative of thalidomide. It has got cytotoxic, immune-modulator, and anti-angiogenic properties. It is used in combination with dexamethasone to treat patients with multiple myeloma.
Pomalidomide (Pomalyst) Uses:
- Relapsed/ refractory Multiple Myeloma:
- It is used in treatment of multiple myeloma along with dexamethasone in patients who have received at least 2 prior therapies, including lenalidomide and a proteasome inhibitor, and have demonstrated disease progression after or within 60 days of completion of the prior therapy.
Pomalidomide (Pomalyst) Dose in Adults
It is important to note that ANC should be more than 500 cells/mm³ and platelets more than 50,000 cells/mm³ before initiating new cycles of therapy.
Pomalidomide (Pomalyst) Dose in the treatment of relapsed/ refractory multiple myeloma:
- Oral: it is given as 4 mg once a day on days 1 to 21 of 28-day cycles in combination with dexamethasone.
- It is continued until disease progression or unacceptable toxicity has occurred.
- Off-label combinations:
- Oral:
- It is given as 4 mg once a day on days 1 to 21 of 28-day cycles in combination with elotuzumab and dexamethasone until disease progression or unacceptable toxicity have occurred OR
- 4 mg once daily on days 1 to 21 of 28-day cycles that too in combination with daratumumab and dexamethasone until disease progression has stopped.
- Oral:
- Dosage adjustment for concomitant therapy with strong CYP1A2 inhibitors:
- Avoid concurrent use of strong CYP1A2 inhibitors. If concomitant use of strong CYP1A2 inhibitors cannot be avoided, reduce the pomalidomide dose by half of recommended dose.
Use in Children:
Not indicated.
Pomalidomide (Pomalyst) Pregnancy Category: X
- [US Boxed Warning]Pregnancy is not a good time to take pomalidomide.
- Pomalidomide can be used as an analog to thalidomide.
- Thalidomide, a human teratogen known to cause severe birth defects and miscarriages, is known.
- Amelia, phocomelia and bone defects were all observed in humans after thalidomide exposure. Infant mortality can reach 40% within a few hours of birth.
- If a pregnancy occurs during pomalidomide treatment, immediately withhold.
- [US Boxed Warning]Before starting pomalidomide treatment for females with reproductive potential, you should have two negative pregnancy tests.
- You should use two forms of contraceptive method during therapy, and continue them for 4 weeks after you stop.
- Only women with childbearing potential should receive treatment if they can comply with the Pomalyst REMS Program conditions.
- After 4 weeks, the patient must stop trying to conceive.
- Females with reproductive potential should use contraception during treatment, interruptions to treatment and for 4 weeks after the discontinuation of pomalidomide.
- A woman with reproductive potential must use two forms of reliable contraception, or total abstinence of heterosexual intercourse, even if she has a history of infertility.
- One method of birth control that is reliable includes tubal ligation (eg., IUD, hormone [birth control pills or injections, patches, vaginal rings or implants], partner's vasectomy, or tubal ligation) and one other method (eg., male latex, synthetic condom, diaphragm or cervical cap).
- Before beginning therapy, pregnancy tests should be performed 10-14 days and 24 hours before starting treatment.
- For the first 4 weeks, then weekly and every 4 weeks thereafter (every 2 week if your menstrual cycle is irregular). Therapy interruptions are for at most 4 weeks.
- Pomalidomide should be immediately stopped if there is a missed period or abnormal pregnancy test.
- If pregnancy is suspected during treatment, the patient should be referred immediately to a specialist in reproductive toxicology.
- The semen of males who take this medication contains pomalidomide.
- The vasectomized males should use a latex condom or synthetic condom for any sexual contact with females of childbearing years during treatment, interruptions and 4 weeks after discontinuation.
- Patients undergoing therapy should avoid sperm donation.
- Any suspicion of fetal exposure should go to the FDA via MedWatch (1-800-3321088) or to Celgene Corporation (1-1-888-423-5436).
Use of pomalidomide while breastfeeding
- It is unknown if breast milk contains it.
- It can cause serious side effects and should not be used during breastfeeding. If therapy is to continue, the clinician must assess whether the benefits outweigh any risks.
Pomalidomide (Pomalyst) Dose in Kidney Disease:
- CrCl ≥15 to <60 mL/minute:
- There are no dosage adjustments provided in the literature. When compared to patients with normal renal function, pomalidomide pharmacokinetics were not significantly altered in patients with CrCl between 15 to 60 mL/minute.
- Hemodialysis:
- Initially, it is given as 3 mg once a day. it should be administered after hemodialysis on dialysis days. Hemodialysis can remove pomalidomide from circulation.
- CrCl <45 mL/minute, including hemodialysis (off-label):
- Results from a phase II study of pomalidomide in combination with low-dose dexamethasone for treatment of relapsed or refractory multiple myeloma suggest that pomalidomide 4 mg once daily (for 21 days of a 28-day treatment cycle) was safe and effective in patients with CrCl <45 mL/minute, including patients requiring hemodialysis.
- The International Myeloma Working Group (IMWG) recommendations:
- The IMWG recommends use of the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (preferred) or the Modification of Diet in Renal Disease (MDRD) formula to evaluate renal function estimation in multiple myeloma patients with a stable serum creatinine.
- CrCl ≥45 mL/minute:
- No dose adjustments are needed.
Pomalidomide (Pomalyst) Dose in Liver disease:
- Hepatic impairment prior to treatment:
- Mild or moderate impairment (Child-Pugh class A or B):
- Initially, it is given as 3 mg once a day.
- Severe impairment (Child-Pugh class C):
- Initially, it is given as 2 mg once a day
- Mild or moderate impairment (Child-Pugh class A or B):
- Hepatic impairment during treatment:
- If liver enzymes are elevated, stop pomalidomide, and evaluate. When liver enzymes return to baseline, one might consider restarting pomalidomide at a lower dose.
Common Side Effects of Pomalidomide (Pomalyst):
- Cardiovascular:
- Peripheral Edema
- Central Nervous System:
- Fatigue
- Dizziness
- Peripheral Neuropathy
- Neuropathy
- Headache
- Anxiety
- Confusion
- Dermatologic:
- Skin Rash
- Pruritus
- Endocrine & Metabolic:
- Hypercalcemia
- Weight Loss
- Hypokalemia
- Hyperglycemia
- Hyponatremia
- Gastrointestinal:
- Constipation
- Nausea
- Diarrhea
- Decreased Appetite
- Vomiting
- Hematologic & Oncologic:
- Neutropenia
- Anemia
- Thrombocytopenia
- Leukopenia
- Neuromuscular & Skeletal:
- Weakness
- Back Pain
- Musculoskeletal Chest Pain
- Muscle Spasm
- Arthralgia
- Myasthenia
- Musculoskeletal Pain
- Ostealgia
- Renal:
- Increased Serum Creatinine
- Renal Failure
- Respiratory:
- Upper Respiratory Tract Infection
- Dyspnea
- Pneumonia
- Cough
- Epistaxis
- Miscellaneous:
- Fever
Less Common Side Effects Of Pomalidomide (Pomalyst):
- Central Nervous System:
- Chills
- Insomnia
- Dermatologic:
- Xeroderma
- Hyperhidrosis
- Endocrine & Metabolic:
- Dehydration
- Hypocalcemia
- Genitourinary:
- Urinary Tract Infection
- Hematologic & Oncologic:
- Febrile Neutropenia
- Lymphocytopenia
- Infection:
- Sepsis
- Neuromuscular & Skeletal:
- Tremor
- Limb Pain
- Respiratory:
- Productive Cough
- Oropharyngeal Pain
- Miscellaneous:
- Night Sweats
Frequency of Side effects Not Defined:
- Cardiovascular:
- Angina Pectoris
- Atrial Fibrillation
- Congestive Cardiac Failure
- Hypotension
- Myocardial Infarction
- Septic Shock
- Syncope
- Central Nervous System:
- Altered Mental Status
- Falling
- Impaired Consciousness
- Noncardiac Chest Pain
- Vertigo
- Dermatologic:
- Cellulitis
- Endocrine & Metabolic:
- Hyperkalemia
- Gastrointestinal:
- Abdominal Pain
- Clostridioides Difficile
- Genitourinary:
- Pelvic Pain
- Urinary Retention
- Urosepsis
- Hepatic:
- Hyperbilirubinemia
- Increased Serum ALT
- Infection:
- Bacteremia
- Neutropenic Sepsis
- Viral Infection
- Neuromuscular & Skeletal:
- Bone Fracture
- Vertebral Compression Fracture
- Respiratory:
- Bronchospasm
- Interstitial Pulmonary Disease
- Lobar Pneumonia
- Pneumonia Due To Pneumocystis Carinii
- Respiratory Syncytial Virus Infection
- Miscellaneous:
- Failure To Thrive
- Multiorgan Failure
- Physical Health Deterioration
Contraindications to Pomalidomide (Pomalyst):
- Pregnancy
- Canadian labeling: Additional contraindications not in the US labeling
- Hypersensitivity to thalidomide or lenalidomide or any other component of the formulation is an absolute contraindication.
- Breastfeeding
- Two effective methods of contraception are not available to women with childbearing potential.
- Male patients are unable to adhere to contraceptive measures.
Warnings and precautions
- Suppression of bone marrow
- In clinical trials, anemia, neutropenia, and thrombocytopenia were all frequently reported. The most common grade 3/4 adverse events were anemia and neutropenia.
- Neutropenic fever was also seen.
- For the first 8 weeks, monitor complete blood counts weekly.
- Then, every other week or as indicated by the doctor thereafter, you will need to check them monthly.
- Depending on the patient's counts, therapy may need to be interrupted, reduced or discontinued.
- CNS effects
- It can cause confusion or dizziness. It is important to exercise caution when operating machinery or driving.
- Avoid taking concurrent medications, as they can cause confusion and dizziness.
- Hepatotoxicity
- There have been reports of fatalities due to hepatic dysfunction. Elevated bilirubin levels and elevated ALT were also reported.
- Perform liver function tests regularly.
- Consider stopping treatment for high liver enzymes, and reducing doses after enzymes return back to baseline.
- Hypersensitivity reactions
- Reports of angioedema, severe cutaneous reactions such as Stevens-Johnson Syndrome [SJS], toxic epidermal Necrolysis [TEN], and drug reactions with eosinophilia or systemic symptoms [DRESS] were all reported.
- DRESS can manifest as a cutaneous reaction, such as a rash, exfoliative, or dermatitis.
- It may also cause eosinophilia and fever. There may also be lymphadenopathy with systemic problems, which could include hepatitis and myocarditis.
- Stop treating angioedema, skin peeling, bullae, or any other severe cutaneous reactions such as SJS, TEN and DRESS. Do not resume therapy in such situations.
- Interstitial lung disease (ILD).
- There have been reports of ILD and other related events, such as pneumonitis.
- Neuropathy
- Clinical trials showed peripheral and sensory neuropathy in some cases, but no cases of grade 4-related neuropathy.
- Pay attention to any signs and symptoms of neuropathy. This may lead to therapy interruption, dose adjustment, or discontinuation.
- Secondary malignancy
- Patients who received pomalidomide for the investigation of multiple myeloma have been diagnosed with acute myelogenous lymphoma (AML).
- [US Boxed Warning]: Thromboembolic Events
- Multiple myeloma patients have experienced venous and arterial events, including pulmonary embolism (PE), deep vein thrombosis, stroke, and pulmonary embolism (DVT) during pomalidomide therapy.
- Antithrombotic prophylaxis was used in clinical trials.
- Thromboprophylaxis should be considered and should be based upon the patient's underlying risks.
- Cerebrovascular ischemia, ischemic heart disease and cerebrovascular thrombotic events are also examples of arterial thrombotic activities.
- If you notice signs and symptoms of thromboembolism, such as shortness of breath, chest pain or arm or leg swelling, be sure to alert your doctor immediately.
- Tumor lysis syndrome
- Patients with high tumor burdens should be closely monitored for signs of tumor lysis syndrome.
- It is important to manage hyperuricemia actively
- Hepatic impairment
- It is important to be cautious as it is metabolized by the liver. In such cases, the risk of systemic exposure increases.
- Patients with hepatic impairment should be adjusted the first dose.
- Multiple myeloma
- Two clinical studies showed an increase in mortality in patients with multiple myeloma treated with pembrolizumab and thalidomide analogs, as well as dexamethasone.
- The experimental arm, which contained pembrolizumab and dexamethasone and a thalidomide analogue [pomalidomide and lenalidomide], was responsible for myocarditis and Stevens-Johnson Syndrome, MI, pericardial bleeding, cardiac failure, respiratory infection, neutropenic seizures, sepsis with multiple organ dysfunction, respiratory failure and intestinal ischemia. It also included suicide, cardiac arrest, pulmonary embolism and cardiac arrest.
- Multiple myeloma has not been approved for PD-1 and PD-L1 blocking antibody treatment.
- Pembrolizumab should never be used in conjunction with thalidomide analogs or dexamethasone to treat multiple myeloma unless it is part of a clinical trial.
- Renal impairment
- Manufacturers recommend making initial dose adjustments.
Pomalidomide: Drug Interaction
Abiraterone Acetate |
May increase the serum concentration of CYP1A2 Substrates (High risk with Inhibitors). |
Alcohol (Ethyl) |
CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). |
Alizapride |
May enhance the CNS depressant effect of CNS Depressants. |
Bisphosphonate Derivatives |
|
Brexanolone |
CNS Depressants may enhance the CNS depressant effect of Brexanolone. |
Brimonidine (Topical) |
May enhance the CNS depressant effect of CNS Depressants. |
Bromopride |
May enhance the CNS depressant effect of CNS Depressants. |
Cannabidiol |
May enhance the CNS depressant effect of CNS Depressants. |
Cannabis |
May enhance the CNS depressant effect of CNS Depressants. |
Chloramphenicol (Ophthalmic) |
May enhance the adverse/toxic effect of Myelosuppressive Agents. |
Chlorphenesin Carbamate |
May enhance the adverse/toxic effect of CNS Depressants. |
CloZAPine |
Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. |
CNS Depressants |
May enhance the adverse/toxic effect of other CNS Depressants. |
Coccidioides immitis Skin Test |
Immunosuppressants may diminish the diagnostic effect of Coccidioides immitis Skin Test. |
CYP1A2 Inhibitors (Moderate) |
May decrease the metabolism of CYP1A2 Substrates (High risk with Inhibitors). |
Deferasirox |
May increase the serum concentration of CYP1A2 Substrates (High risk with Inhibitors). |
Denosumab |
May enhance the adverse/toxic effect of Immunosuppressants. Specifically, the risk for serious infections may be increased. |
Dimethindene (Topical) |
May enhance the CNS depressant effect of CNS Depressants. |
Doxylamine |
May enhance the CNS depressant effect of CNS Depressants. Management: The manufacturer of Diclegis (doxylamine/pyridoxine), intended for use in pregnancy, specifically states that use with other CNS depressants is not recommended. |
Dronabinol |
May enhance the CNS depressant effect of CNS Depressants. |
Erythropoiesis-Stimulating Agents |
May enhance the thrombogenic effect of Pomalidomide. |
Esketamine |
May enhance the CNS depressant effect of CNS Depressants. |
HydrOXYzine |
May enhance the CNS depressant effect of CNS Depressants. |
Kava Kava |
May enhance the adverse/toxic effect of CNS Depressants. |
Lofexidine |
May enhance the CNS depressant effect of CNS Depressants. Management: Drugs listed as exceptions to this monograph are discussed in further detail in separate drug interaction monographs. |
Magnesium Sulfate |
May enhance the CNS depressant effect of CNS Depressants. |
Mesalamine |
May enhance the myelosuppressive effect of Myelosuppressive Agents. |
MetyroSINE |
CNS Depressants may enhance the sedative effect of MetyroSINE. |
Minocycline |
May enhance the CNS depressant effect of CNS Depressants. |
Mirtazapine |
CNS Depressants may enhance the CNS depressant effect of Mirtazapine. |
Nabilone |
May enhance the CNS depressant effect of CNS Depressants. |
Obeticholic Acid |
May increase the serum concentration of CYP1A2 Substrates (High risk with Inhibitors). |
Ocrelizumab |
May enhance the immunosuppressive effect of Immunosuppressants. |
Peginterferon Alfa-2b |
May increase the serum concentration of CYP1A2 Substrates (High risk with Inhibitors). |
Pidotimod |
Immunosuppressants may diminish the therapeutic effect of Pidotimod. |
Piribedil |
CNS Depressants may enhance the CNS depressant effect of Piribedil. |
Pramipexole |
CNS Depressants may enhance the sedative effect of Pramipexole. |
Promazine |
May enhance the myelosuppressive effect of Myelosuppressive Agents. |
ROPINIRole |
CNS Depressants may enhance the sedative effect of ROPINIRole. |
Rotigotine |
CNS Depressants may enhance the sedative effect of Rotigotine. |
Rufinamide |
May enhance the adverse/toxic effect of CNS Depressants. Specifically, sleepiness and dizziness may be enhanced. |
Selective Serotonin Reuptake Inhibitors |
CNS Depressants may enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Specifically, the risk of psychomotor impairment may be enhanced. |
Siponimod |
Immunosuppressants may enhance the immunosuppressive effect of Siponimod. |
Tertomotide |
Immunosuppressants may diminish the therapeutic effect of Tertomotide. |
Tetrahydrocannabinol |
May enhance the CNS depressant effect of CNS Depressants. |
Tetrahydrocannabinol and Cannabidiol |
May enhance the CNS depressant effect of CNS Depressants. |
Tobacco (Smoked) |
May enhance the adverse/toxic effect of Pomalidomide. Specifically, the risk for thrombosis may be increased. Tobacco (Smoked) may decrease the serum concentration of Pomalidomide. |
Trastuzumab |
May enhance the neutropenic effect of Immunosuppressants. |
Trimeprazine |
May enhance the CNS depressant effect of CNS Depressants. |
Risk Factor D (Consider therapy modification) |
|
Baricitinib |
Immunosuppressants may enhance the immunosuppressive effect of Baricitinib. Management: Use of baricitinib in combination with potent immunosuppressants such as azathioprine or cyclosporine is not recommended. Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted. |
Blonanserin |
CNS Depressants may enhance the CNS depressant effect of Blonanserin. |
Buprenorphine |
CNS Depressants may enhance the CNS depressant effect of Buprenorphine. Management: Consider reduced doses of other CNS depressants, and avoiding such drugs in patients at high risk of buprenorphine overuse/self-injection. Initiate buprenorphine at lower doses in patients already receiving CNS depressants. |
Chlormethiazole |
May enhance the CNS depressant effect of CNS Depressants. Management: Monitor closely for evidence of excessive CNS depression. The chlormethiazole labeling states that an appropriately reduced dose should be used if such a combination must be used. |
Ciprofloxacin (Systemic) |
May increase the serum concentration of Pomalidomide. Management: Avoid concomitant use of pomalidomide and ciprofloxacin when possible. If coadministration is considered necessary, consider reducing the pomalidomide dose 50% and monitoring patients for increased pomalidomide effects/toxicities. |
CYP1A2 Inhibitors (Strong) |
May increase the serum concentration of Pomalidomide. Management: Avoid when possible. If coadministration is necessary, reduce the pomalidomide dose 50% and monitor for increased pomalidomide effects/toxicities. |
Deferiprone |
Myelosuppressive Agents may enhance the neutropenic effect of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. |
Droperidol |
May enhance the CNS depressant effect of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (eg, opioids, barbiturates) with concomitant use. Exceptions to this monograph are discussed in further detail in separate drug interaction monographs. |
Echinacea |
May diminish the therapeutic effect of Immunosuppressants. |
Estrogen Derivatives |
Pomalidomide may enhance the thrombogenic effect of Estrogen Derivatives. Management: Canadian pomalidomide labeling recommends caution with use of hormone replacement therapy and states that hormonal contraceptives are not recommended. US pomalidomide labeling does not contain these specific recommendations. |
Fingolimod |
Immunosuppressants may enhance the immunosuppressive effect of Fingolimod. Management: Avoid the concomitant use of fingolimod and other immunosuppressants when possible. If combined, monitor patients closely for additive immunosuppressant effects (eg, infections). |
Flunitrazepam |
CNS Depressants may enhance the CNS depressant effect of Flunitrazepam. |
HYDROcodone |
CNS Depressants may enhance the CNS depressant effect of HYDROcodone. Management: Avoid concomitant use of hydrocodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. |
Leflunomide |
Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly. |
Methotrimeprazine |
CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Methotrimeprazine may enhance the CNS depressant effect of CNS Depressants. Management: Reduce adult dose of CNS depressant agents by 50% with initiation of concomitant methotrimeprazine therapy. Further CNS depressant dosage adjustments should be initiated only after clinically effective methotrimeprazine dose is established. |
Nivolumab |
Immunosuppressants may diminish the therapeutic effect of Nivolumab. |
Opioid Agonists |
CNS Depressants may enhance the CNS depressant effect of Opioid Agonists. Management: Avoid concomitant use of opioid agonists and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. |
OxyCODONE |
CNS Depressants may enhance the CNS depressant effect of OxyCODONE. Management: Avoid concomitant use of oxycodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. |
Perampanel |
May enhance the CNS depressant effect of CNS Depressants. Management: Patients taking perampanel with any other drug that has CNS depressant activities should avoid complex and high-risk activities, particularly those such as driving that require alertness and coordination, until they have experience using the combination. |
Progestins |
May enhance the thrombogenic effect of Pomalidomide. Management: Canadian pomalidomide labeling recommends caution with use of hormone replacement therapy and states that hormonal contraceptives are not recommended. US pomalidomide labeling does not contain these specific recommendations. |
Roflumilast |
May enhance the immunosuppressive effect of Immunosuppressants. |
Sipuleucel-T |
Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Management: Evaluate patients to see if it is medically appropriate to reduce or discontinue therapy with immunosuppressants prior to initiating sipuleucel-T therapy. |
Sodium Oxybate |
May enhance the CNS depressant effect of CNS Depressants. Management: Consider alternatives to combined use. When combined use is needed, consider minimizing doses of one or more drugs. Use of sodium oxybate with alcohol or sedative hypnotics is contraindicated. |
Suvorexant |
CNS Depressants may enhance the CNS depressant effect of Suvorexant. Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended. |
Tapentadol |
May enhance the CNS depressant effect of CNS Depressants. Management: Avoid concomitant use of tapentadol and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. |
Tofacitinib |
Immunosuppressants may enhance the immunosuppressive effect of Tofacitinib. Management: Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted, and this warning seems particularly focused on more potent immunosuppressants. |
Vaccines (Inactivated) |
Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. |
Vemurafenib |
May increase the serum concentration of CYP1A2 Substrates (High risk with Inhibitors). Management: Consider alternatives to such combinations whenever possible, particularly if the CYP1A2 substrate has a relatively narrow therapeutic index. Drugs listed as exceptions to this monograph are discussed in separate drug interaction monographs. |
Zolpidem |
CNS Depressants may enhance the CNS depressant effect of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. |
Risk Factor X (Avoid combination) |
|
Abatacept |
Anti-TNF Agents may enhance the adverse/toxic effect of Abatacept. An increased risk of serious infection during concomitant use has been reported. |
Anakinra |
Anti-TNF Agents may enhance the adverse/toxic effect of Anakinra. An increased risk of serious infection during concomitant use has been reported. |
Azelastine (Nasal) |
CNS Depressants may enhance the CNS depressant effect of Azelastine (Nasal). |
BCG (Intravesical) |
Immunosuppressants may diminish the therapeutic effect of BCG (Intravesical). |
BCG (Intravesical) |
Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). |
Bromperidol |
May enhance the CNS depressant effect of CNS Depressants. |
Canakinumab |
Anti-TNF Agents may enhance the adverse/toxic effect of Canakinumab. Specifically, the risk for serious infections and/or neutropenia may be increased. |
Certolizumab Pegol |
Anti-TNF Agents may enhance the immunosuppressive effect of Certolizumab Pegol. |
Cladribine |
May enhance the immunosuppressive effect of Immunosuppressants. |
Cladribine |
May enhance the myelosuppressive effect of Myelosuppressive Agents. |
Dipyrone |
May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased |
Natalizumab |
Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. |
Orphenadrine |
CNS Depressants may enhance the CNS depressant effect of Orphenadrine. |
Oxomemazine |
May enhance the CNS depressant effect of CNS Depressants. |
Paraldehyde |
CNS Depressants may enhance the CNS depressant effect of Paraldehyde. |
Pembrolizumab |
May enhance the adverse/toxic effect of Thalidomide Analogues. Specifically, mortality may be increased when this combination is used for treatment of refractory multiple myeloma. |
Pimecrolimus |
May enhance the adverse/toxic effect of Immunosuppressants. |
Rilonacept |
Anti-TNF Agents may enhance the adverse/toxic effect of Rilonacept. |
Tacrolimus (Topical) |
May enhance the adverse/toxic effect of Immunosuppressants. |
Thalidomide |
CNS Depressants may enhance the CNS depressant effect of Thalidomide. |
Tocilizumab |
May enhance the immunosuppressive effect of Anti-TNF Agents. |
Vaccines (Live) |
Immunosuppressants may enhance the adverse/toxic effect of Vaccines (Live). Immunosuppressants may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live organism vaccines with immunosuppressants; live-attenuated vaccines should not be given for at least 3 months after immunosuppressants. |
Vedolizumab |
Anti-TNF Agents may enhance the adverse/toxic effect of Vedolizumab. |
Monitoring parameters:
- CBC with differential and platelets weekly during the first 8 weeks, and then monthly or as required by clinical necessity thereafter.
- Renal function, i.e. serum creatinine and creatinine clearance
- Monthly liver function tests.
- Monitor patients at high risk for thromboembolism, neuropathy and tumor lysis syndrome.
- Thyroid function tests (TSH) are recommended at baseline, and every 2 to 3-months during treatment for structurally related medications.
- Monitor compliance.
Females with childbearing potential
- Pregnancy test 10-14 days and 24 hours before initiating therapy. This is for women who have regular periods, or women who have irregular periods.
- After discontinuing pregnancy tests, you should continue to have your pregnancies tested for at least four weeks.
How to administer Pomalidomide (Pomalyst)?
- Administer without regard to meals.
- Swallow whole with water.
- Do not break, chew, or open the capsules.
Missed doses:
- One can administer a missed dose if within 12 hours of the usual dosing time.
- If more than 12 hours have elapsed, then skip the dose for that day and resume the usual dosing the following day.
- Do not take 2 doses to make up for a skipped dose.
Mechanism of action of Pomalidomide (Pomalyst):
- Pomalidomide causes cell cycle arrest and apoptosis in multiple myeloma cells.
- It increases T cell- and natural killer cell-mediated cytotoxicity, inhibits proinflammatory cytokines tumor nefara (TNFa), IL-1 and IL-6 and inhibits angiogenesis.
Absorption:
- Rapid;
- slowed by food.
Distribution: Semen distribution is ~67% of plasma levels
Protein binding:
- 12% to 44%
Metabolism:
- Hepatic via CYP1A2 and CYP3A4.
- Via CYP2C19 and CYP2D6 (minor)
Half-life elimination:
- About 9.5 hours (healthy subjects).
- About7.5 hours (multiple myeloma patients)
Time to peak:
- 2 to 3 hours
Excretion:
- Urine (73%; 2% as unchanged drug).
- Via feces (15%; 8% as unchanged drug)
International Brand Names of Pomalidomide:
- Pomalyst
- Imnovid
Pomalidomide Brand Names in Pakistan:
No Brands Available in Pakistan.