Universal reference book for medicines
Name of the preparation: IMNOVID ® (IMNOVID ® )

Active substance: pomalidomide

Type: Immunomodulator with antitumor activity

Manufacturer: CELGENE INTERNATIONAL (Switzerland)
Composition, form of production and packaging
Capsules
gelatinous, №4, with dark blue opaque lid with marked on it marking with white ink "POML" and yellow opaque case with marked on it marking with black ink "1 mg";
the contents of the capsules are a yellow powder.
1 caps.

pamildomide 1 mg

Excipients: mannitol - 53.68 mg, pregelatinized starch - 70 mg, sodium stearyl fumarate - 0.32 mg.

The composition of the capsule shell: lid - gelatin - 14.915 mg, titanium dioxide - 0.179 mg, indigocarmine - 0.106 mg, white ink *;
body - gelatin - 22.566 mg, titanium dioxide - 0.18 mg, iron oxide yellow - 0.054 mg, black ink *.

* composition of ink for the marking of the capsule (%, by weight):
white ink - shellac (0.45% solution in ethanol) - 52%, titanium dioxide - 30%, simethicone - 0.01%, propylene glycol - 1%, ammonium hydroxide (28% solution ) - 2%, isopropanol - 14%, n-butanol - 1%;
black ink - shellac (0.45% solution in ethanol) - 59.4%, propylene glycol - 1.3%, ammonium hydroxide (28% solution) - 0.001%, isopropanol 0.6%, n-butanol 9.8%, iron oxide black 24.7% ethanol anhydrous - 1.1%, purified water - 3.2%.
7 pcs.
- blisters (3) - packs of cardboard.
Capsules gelatinous, №2, with a dark blue opaque lid with marked on it marking with white ink "POML" and green opaque case with marked on it marking with white ink "3 mg";
the contents of the capsules are a yellow powder.
1 caps.

pologmidomide 3 mg

Excipients: mannitol - 75.75 mg, pregelatinized starch - 100.8 mg, sodium stearyl fumarate - 0.45 mg.

The composition of the capsule shell: cap - gelatin - 23.943 mg, titanium dioxide - 0.287 mg, indigocarmine - 0.171 mg, white ink *;
body - gelatin - 35.906 mg, titanium dioxide - 0.599 mg, iron oxide yellow - 0.077 mg, indigocarmine - 0.017 mg, white ink *.

* composition of ink for the marking of the capsule (%, by weight):
white ink - shellac (0.45% solution in ethanol) - 52%, titanium dioxide - 30%, simethicone - 0.01%, propylene glycol - 1%, ammonium hydroxide (28% solution ) - 2%, isopropanol - 14%, n-butanol - 1%.

7 pcs.
- blisters (3) - packs of cardboard.
Capsules gelatinous, №2, with a dark blue opaque lid with marked on it marking with white ink "POML" and blue opaque case with marked on it marking with white ink "4 mg";
the contents of the capsules are a yellow powder.
1 caps.

pologidomide 4 mg

Excipients: mannitol - 101 mg, pregelatinized starch - 134.4 mg, sodium stearyl fumarate - 0.6 mg.

The composition of the capsule shell: cap - gelatin - 23.943 mg, titanium dioxide - 0.287 mg, indigocarmine - 0.171 mg, white ink *;
body - gelatin - 35.73 mg, titanium dioxide - 0.815 mg, diamond blue FCF - 0.056 mg, white ink *.

* composition of ink for the marking of the capsule (%, by weight):
white ink - shellac (0.45% solution in ethanol) - 52%, titanium dioxide - 30%, simethicone - 0.01%, propylene glycol - 1%, ammonium hydroxide (28% solution ) - 2%, isopropanol - 14%, n-butanol - 1%.

7 pcs.
- blisters (3) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2015.

PHARMACHOLOGIC EFFECT

Mechanism of action

Pomalidomide has a direct anti-myeloma tumorocidal activity, demonstrates immunomodulatory action and inhibits stromal cells that support the growth of myeloma tumor cells.
Pomalidomide selectively inhibits proliferation and causes apoptosis of hematological cells of the tumor. In addition, pologidomide inhibits the proliferation of multiple myeloma cell lines resistant to lenalidomide, and has synergism with dexamethasone in the ability to induce apoptosis of both sensitive and lenalidomide-resistant tumor cell lines. Pomalidomide enhances cellular immunity with the participation of T cells and natural killers and inhibits the formation of pro-inflammatory cytokines (eg, tumor necrosis factor-a, TNF-a, and interleukin-6, IL-6) by monocytes. Pomalidomide also inhibits angiogenesis, blocking the migration and adhesion of endothelial cells.
PHARMACOKINETICS

Absorption

After a single oral intake, the amount of absorption of pamildomide is at least 73% and its C max in blood plasma is reached after 2-3 hours. Systemic exposure to pamildomide (according to AUC, the area under the concentration-time curve) increases almost linearly and in proportion to the dose.
With multiple dosing, the degree of accumulation of pamildomide is 27-31% in AUC.
When taken together with a high-calorie food with a significant fat content, the rate of absorption of pamildomide slows down, the C max decreases by about 25%, but the total intake practically does not change, the AUC decreases by only 8%.
Therefore, pologiadomide can be taken regardless of food intake.
Distribution

The average apparent volume of distribution (V d / K) of pologidomide at equilibrium concentration is in the range of 62-138 liters.
After applying pamildomide for 4 days to 2 mg per day, it is found in the seminal fluid of healthy volunteers at a concentration of approximately 67% of the plasma level, which is achieved after 4 hours (approximate T max ) after taking the drug. In vitro binding of enantiomers of pologmidomide with human plasma proteins is in the range from 12% to 44% and is independent of concentration.
Biotransformation

In healthy volunteers, after a single ingestion of [ 14 C] -palamidomide (2 mg), the main component in the blood was pologidomide (approximately 70% of the plasma radioactivity level).
The amount of metabolites did not exceed 10% relative to the starting compound or the total plasma radioactivity level.
Hydroxylation followed by glucuronization or hydrolysis is the main metabolic pathway.
In vitro isoenzymes of the cytochrome P450, CYP1A2 and CYP3A4 system were found to be the main enzymes involved in the hydroxylation of pologidomide. The isoenzymes CYP2C19 and CYP2D6 were of less importance. Pomalidomide is also a substrate of P-glycoprotein in vitro. The combined use of pamildomide with the active inhibitor CYP3A4 / 5 and P-gp ketoconazole or with the powerful inducer CYP3A4 / 5 carbamazepine did not have a clinically significant effect on the exposure of pologidomide. The combined use of the active inhibitor of CYP1A2 fluvoxamine and the presence of ketoconazole increased the effect of pamildomide by 104% at 90% confidence interval [88% -122% | in comparison with the combination of pamidomide-ketoconazole. If an active inhibitor of CYP1A2 (eg ciprofloxacin, enoxacin and fluvoxamine) is used in conjunction with pamalidomide, patients should be carefully monitored for the timely detection of unwanted drug reactions (NLR).
Based on in vitro data, pamalidomide does not induce or inhibit the isoenzymes of the cytochrome P450 system.
Do not use other studied drug transporters. When combining pamildomide with substrates of such pathways, clinically significant drug interactions are unlikely.
Excretion

The mean T.sub.1 of polimalomide from plasma was 9.5 h in healthy volunteers and 7.5 h in patients with multiple myeloma.
The average total clearance (CL / F) of the drug is approximately 7-10 l / h. In healthy volunteers, after a single oral intake of [ 14 C! -pomaldomide (2 mg), approximately 73% and 15% of the radioactive dose were excreted through the kidneys and intestines. At the same time, about 2% and 8% of the dose of polimedomide with a carbon label was excreted through the kidneys and intestines in unchanged form.
Pomalidomide is largely biotransformation, and the resulting metabolites are excreted mainly through the kidneys.
The three main metabolites formed as a result of hydrolysis or hydroxylation followed by glucuronization are, respectively, 23%, 17% and 12% of the total metabolites in the urine.
The amount of metabolites formed with the participation of cytochrome P450 was approximately 43% of the total radioactivity, and the non-CYP dependent hydrolytic metabolites was 25%.
In unmodified form, 10% of pologidomide (2% - through the kidneys and 8% through the intestine).
Children and teens

There are no data on the use of pamildomide in children and adolescents (<18 years).

Elderly

Data on the pharmacokinetics of pamildomide in elderly patients are not available. Clinical studies did not require dose changes in patients older than 65 years who received pologidomide (see "Method of administration and dose").

Renal insufficiency

Studies of pamildomide in patients with renal insufficiency have not been conducted.

Liver failure

Studies of pamildomide in patients with hepatic insufficiency have not been conducted.

Pre-clinical safety study results

In a toxicological study in rats, pologidomide was well tolerated at doses of 50, 250 and 1000 mg / kg / day with multiple dosing for 6 months.
There were no undesirable reactions to the drug when dosing pologiadomide up to 1000 mg / kg / day (175 times higher than the therapeutic dose of 4 mg). Pomalidomide did not show a mutagenic effect and did not cause chromosomal aberrations in human peripheral blood lymphocytes or micronucleation in polychromatic erythrocytes of bone marrow of rats at doses up to 2000 mg / kg / dL. Pomalidomide had a teratogenic effect in both rats and rabbits when applied during the main organogenesis.
INDICATIONS

- in combination with dexamethasone for the treatment of adult patients with recurrent and refractory multiple myeloma who received at least two previous courses of treatment, including both lenalidomide and bortezomib, and who had progression of the disease on the background of the last treatment.

DOSING MODE

For oral administration.

Treatment with the drug should be started and carried out only under the supervision of a physician experienced in the treatment of multiple myeloma.

Imnovid ® should be taken every day at the same time.
Capsules can not be opened, broken or chewed. Capsules of Imnovid ® should be swallowed whole, washed down with water, regardless of food intake. If the patient forgot to take Imnovide ® any day, then the next day he should take the usual dose in accordance with the appointment. The patient should not change the dose of the drug to make up for the dose missed the day before.
The recommended initial dose of Imnovid ® is 4 mg orally 1 time / day from 1 to 21 days of repeated 28-day cycles.

The recommended dose of dexamethasone is 40 mg orally once a day at 1, 8, 15 and 22 days of each 28-day cycle.

The dosage regimen is maintained or changed depending on the clinical and laboratory data.

Treatment should be stopped when the disease progresses.

Change in the dose of pologidomide or discontinuation of treatment

Instructions for discontinuing treatment or changing the dose of pamildomide due to unwanted hematologic reactions are presented in the table below:

Instructions for changing the dose of pologidomide

Toxicity Change in dose

Hsitropenia

ACN * <0.5 × 10 9 / L or megal neutropenia (temperature? 38.5 ° C and ACH <1 × 10 9 / L) Interrupt treatment with pomidomide, weekly OAK **

AKN was restored to values ​​of ≥10 9 / l Renew treatment with pamildomide at a dose of 3 mg / day

For each subsequent decrease <0.5 × 10 9 / L Terminate treatment with pomidomide

AKN was restored to values ​​of? 10 9 / l Renew treatment with pomildomide at a dose of 1 mg lower than the previous

Thrombocytopenia

The number of platelets is <25 × 10 9 / l Terminate treatment with pologidomide, weekly OAK **

The number of platelets was restored to values ​​of ≥50 × 10 9 / L Renewal of treatment with pologidomide at a dose of 3 mg / day

For each subsequent decrease, <25? 10 9 / L Terminate treatment with pomalidomide

The number of platelets was restored to ≥50 × 10 9 / L Renewal of treatment with pomildomide at a dose of 1 mg lower than the previous

* ACN is the absolute number of neutrophils;
** UAC - a general blood test.
To start a new cycle of treatment with pamildomide, the amount of neutrophils should be? 1 × 10 9 / l, and the number of platelets? 50 × 10 9 / L.

With neutropenia, the doctor should consider the use of growth factor drugs.

In case of undesired reactions of grade 3 or 4 associated with pamildomide, treatment should be suspended and resumed at a dose of 1 mg lower than the previous one if the treating physician estimates that the severity of the undesirable phenomenon is reduced to 2 or less.

If unwanted reactions persist after lowering the dose to 1 mg, the drug should be discontinued.

Instructions for changing the dose of dexamethasone

Toxicity Change in the dose of dexamethasone

Dyspepsia 1-2 degrees Dyspepsia? 3 degrees Maintain a dose and apply histamine blockers (H 2 ) or similar agents.
Reduce the dose by one level while maintaining the symptoms. Interrupt treatment until symptoms ease. Add histamine blockers (H 2 ) or similar agents and reduce the dose to one level upon resumption of treatment.
Edema? 3 degrees Apply diuretics as needed and reduce the dose by one level.

Confusion and mood changes? 2 degrees Interrupt treatment until symptoms resolve.
When you resume treatment, reduce the dose by one level.
Muscle weakness? 2 degrees Interrupt treatment until the indicator of muscle weakness becomes? 1 degree.
When you resume treatment, reduce the dose by one level.
Hyperglycemia? 3 degrees Reduce the dose by one level.
Use insulin or oral hypoglycemic agents as needed.
Acute pancreatitis Stop treatment with dexamethasone.

Other non-aspirant events? 3 degrees due to dexamethasone Interrupt treatment with dexamethasone until the values ​​of undesirable phenomena become? 2 degrees.Resume the treatment, lowering the dose by one level.

Decrease in the dose of dexamethasone:

The order of dose reduction (patients ≥75 years of age): initial dose of 40 mg;
dose of 1 level - 20 mg; dose 2 level - 10 mg at 1, 8, 15 and 22 day of each 28-day treatment cycle.
The order of dose reduction (patients older than 75 years): an initial dose of 20 mg;
dose of 1 level - 12 mg; dose level 2 - 8 mg at 1, 8, 15 and 22 day of each 28-day treatment cycle.
If the toxic effects persist for more than 14 days, the dose of dexamethasone should be reduced by one level.

Peculiarities of application in separate groups of patients

Children and teens

Imnovid ® is not recommended for use in children and adolescents under the age of 18 due to the lack of clinical data on efficacy and safety.

Elderly patients

Change in the dose of pamildomide in patients older than 65 years is not required.
For patients older than 75 years, the initial dose of dexamethasone is 20 mg once every 1, 8, 15 and 22 days of each 28-day treatment cycle.
Impaired renal function

Studies of pamildomide in patients with renal insufficiency have not been conducted.
Patients with moderate or severe renal insufficiency (SC 45 mL / min) were not included in the clinical studies. Patients with renal insufficiency should be carefully monitored for the timely detection of unwanted reactions.
Dysfunction of the liver

Studies of pamildomide in patients with hepatic insufficiency have not been carried out, since.
patients with total serum bilirubin values ​​exceeding 2.0 mg% were not included in the clinical studies. Patients with impaired liver function should be carefully monitored for the timely detection of unwanted reactions.
SIDE EFFECT

Safety Profile Summary

During clinical trials, the most frequent adverse reactions were violations of the blood and lymphatic system: anemia (45.7%), neutropenia (45.3%) and thrombocytopenia (27%);
Among the common disorders, fatigue prevailed (28.3%), fever (21%) and peripheral edema (13%); among infections and parasitic diseases - pneumonia (10.7%). As a side effect, peripheral neuropathy was registered in 12.3% of patients, and venous embolic and thrombotic disorders (VETN) complications - in 3.3% of patients. The most frequent adverse reactions of grade 3 or 4 were violations of blood and lymphatic system, including neutropenia (41.7%), anemia (27%) and thrombocytopenia (20.7%); among infections and invasions - pneumonia (9%); among common disorders and disorders at the site of administration of the drug - fatigue (4.7%), fever (3%) and peripheral edema (1.3%). The most frequent serious adverse reaction was pneumonia (9.3%). Of the other serious adverse events, febrile neutropenia (4.0%), neutropenia (2.0%), thrombocytopenia (1.7%) and VETN (1.7%) were recorded.
Undesirable reactions often occurred during the first two cycles of treatment with pomidomide.

The adverse reactions (NLR) that occurred in patients treated with a combination of pamildomide and dexamethasone are presented below in accordance with the classification of lesions of organs and systems of MEDDRA organs, taking into account the frequency of all HLR and the frequency of HLR 3 or 4 severity.

The frequency of the NLRs given below was determined according to the following classification: very often (> 1/10);
often (> 1/100, <1/10): infrequently (> 1/1000, <1/100).
NLR, registered in clinical studies in patients with refractory multiple myeloma on the background of therapy with pamamidomide and dexamethasone

System-Organ Class Adverse reactions (total), frequency Adverse reactions 3-4 degrees of severity, frequency

Infectious and parasitic diseases Very often: pneumonia.
Often: neutropenic sepsis, bronchopneumonia, bronchitis, acute respiratory infections, acute infectious diseases of the upper respiratory tract, nasopharyngitis. Often: neutropenic sepsis, pneumonia, bronchopneumonia, acute respiratory infections, acute infectious diseases of the upper respiratory tract. Infrequent: bronchitis.
Disorders from the blood and lymphatic system Very often: neutropenia, thrombocytopenia, leukopenia, anemia.
Often: febrile neutropenia. Very often: neutropenia, thrombocytopenia, anemia. Often: febrile neutropenia, leukopenia.
Violations by the metabolism and nutrition Very common: decreased appetite. Common: hyperkalemia, hyponatremia. Common: hyperkalemia, hyponatremia. Uncommon: decreased appetite.
Most mental disorders: confusion. Common: confusion.
Disorders of the nervous system Common: confusion, peripheral sensory neuropathy, dizziness, tremor. Common: confusion. Uncommon: peripheral sensory neuropathy, dizziness, tremor.
Violations by the organ of hearing and labyrinth disorders Common: vertigo. Common: vertigo.
Violations by vessels often: deep vein thrombosis. Infrequent: deep vein thrombosis.
Violations of the respiratory system, organs, thoracic and mediastinal disorders Very common: dyspnoea, cough. Common: pulmonary embolism. Common: shortness of breath. Uncommon: pulmonary embolism, cough.
Violations of the gastrointestinal tract Very common: diarrhea, nausea, constipation. Often vomiting. Common: diarrhea, vomiting, constipation. Uncommon: nausea.
Disorders of the liver and biliary tract Uncommon: hyperbilirubinemia. Uncommon: hyperbilirubinemia.
Violations of the skin and subcutaneous tissue disorders Common: rash, pruritus. Common: rash.
Violations by musculoskeletal and connective tissue disorders Very common: bone pain, muscle spasms. Common: bone pain. Uncommon: muscle spasms.
Violations by the kidneys and urinary tract Common: renal failure, urinary retention. Common: renal failure. Uncommon: urinary retention.
Violations by the genitals and mammary glands often: pelvic pain. Often: pelvic pain.
General disorders and administration site in Very common: fatigue, fever, peripheral edema. Common: fatigue, fever, peripheral edema.
Laboratory and instrumental data Common: neutropenia, leukopenia, thrombocytopenia, increased alanine aminotransferase activity. Common: neutropenia, leukopenia, thrombocytopenia, increased alanine aminotransferase activity.
The description of adverse reactions
Teratogenicity

Pomalidomid structurally similar to thalidomide, a known teratogen that causes severe life-threatening birth defects. Detected pomalidomida teratogenic effect during organogenesis at its main application in rats and rabbits. When applying pomalidomida during pregnancy in humans is probably a manifestation of its teratogenic effects (see. "Contraindications" and "Special instructions").
Neutropenia and thrombocytopenia
Neutropenia was reported in 45.3% of patients receiving pomalidomid in combination with low-dose dexamethasone (Pom + LD-Dex). Neutropenia grade 3 or 4 severity occurred in 41.7% of patients treated with Pom + LD-Dex, wherein the neutropenia was rarely severe (2.0% of patients), did not lead to discontinuation of treatment was the cause of treatment interruption in 21.0% of patients and cause dose reduction in 7.7% of patients.
Febrilpaya neutropenia (FN) was observed in 6.7% of patients on background Pom + LD-Dex. All manifestations have been 3 or 4 severity. FN recognized as serious in 4.0% of patients, was the cause of the break in treatment in 3.7% of patients, the cause of dose reduction - in 1.3% of patients. No patient treatment is not completely subsided. Thrombocytopenia was reported in 27.0% of patients who received Pom + LD-Dex. Thrombocytopenia 3 or 4 severity was at 20.7% of patients with thrombocytopenia is regarded as a serious in 1.7% of patients, the dose caused a decrease in 6.3% suspension of the treatment - 8%, and discontinuation of treatment - in 0.7% of patients.
infection
Infections were the most frequent non-hematological toxicity manifestation: they were recorded in 55.0% of patients in the treatment Pom + LD-Dex. Approximately half of these infections has 3 or 4 degrees. The most frequent complications were pneumonia and upper respiratory infection (10.7% and 9.3% of patients, respectively). In 24.3% of cases of infection were serious, and 2.7% of patients were fatal (5 severity). Infections require discontinuation of treatment in 2.0% of patients discontinuing treatment - 14.3%, and dose reduction - in 1.3% of patients.
thromboembolic complications
Venous embolic or thrombotic complications (ETO) were detected in 3.3% of patients receiving Pom + LD-Dex. These complications 3 or 4 severity were observed in 1.3% of patients in 1.7% of patients ETO recognized serious. ETO is not accompanied by a fatal and did not require discontinuation of treatment.
Prophylactic use of aspirin (or other anticoagulants in high-risk patients) was compulsory. In the absence of contraindications recommended as anticoagulant treatment.
Peripheral Neuropathy

Peripheral neuropathy generally 1 or 2 severity was observed in 12.3% of patients in the treatment Pom + LD-Dex. Reacting 3 or 4 severity reported in 1.0% of patients.
Severe peripheral neuropathy has not developed, and treatment in this regard was discontinued in 0.3% of patients.
Median time to the manifestation of peripheral neuropathy was 2.1 weeks, with fluctuations of 0.1 to 48.3 weeks.
The median time to resolution of this complication was 22.4 weeks.
CONTRAINDICATIONS

- increased sensitivity to pomalidomidu or any other components of the formulation;
- Pregnancy and the period of breastfeeding;

- for women: the saved childbearing potential, except when all the necessary conditions for pregnancy prevention program from {see. "Special instructions");
- men: the inability or failure to comply with the required contraceptive measures referred to in the section "Special instructions";
- Children up to age 18 years (and the lack of efficacy and safety data).
Carefully

- patients with kidney and / or liver failure (see also "Dosage and Administration".), As well as in patients with deep venous thrombosis (including, and history);
- in patients with risk factors for thromboembolic events (heart or lung disease, high blood pressure or high blood levels of cholesterol, smokers);
- during coadministration with drugs that increase the risk of thrombosis, namely, with drugs having erythropoietic activity and hormone replacement therapy (see also "Side effect" and "interaction with other drugs.");
- in patients with advanced stage disease, and / or high tumor load because of the potential risk of tumor lysis syndrome (see "Special instructions.");
- in patients with neuropathy (including history).
PREGNANCY AND LACTATION

Pregnancy

Pomalidomid may have teratogenic effects in humans. The drug is contraindicated during pregnancy and in women with childbearing potential stored, except in compliance with all the conditions for protection against pregnancy (see. "Contraindications" and "Special instructions").
Breastfeeding period

It not determined whether pomalidomid excreted in human breast milk. Pomalidomid detected in the milk of rats to which the drug was administered. Given the possibility of an adverse effect on pomalidomida infants should be discontinued or breastfeeding or the drug, taking into account the importance of taking the drug to the mother.
Fertility

Animals pomalidomid has an adverse effect on fertilyyust and teratogenic effect. Pomalidomid crosses the placenta and is found in the fetal blood (according to the data obtained in rabbits).
APPLICATION FOR FUNCTIONS OF THE LIVER

With caution to patients with primenenyat pochechenoy insufficiency. pomalidomida studies have been conducted in patients with renal insufficiency. Patients with moderate or severe renal failure (creatinine clearance of 45 ml / min) was not included in clinical trials. Patients with renal impairment should be carefully monitored for timely detection of adverse reactions.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Primenenyat with caution to patients with liver failure. pomalidomida studies in patients with hepatic impairment have not been conducted since patients whose total serum bilirubin values ​​greater than 2.0 mg%, were not included in clinical studies. Patients with impaired hepatic function should be monitored closely for early detection of adverse reactions.
APPLICATION FOR CHILDREN

Use of the drug for children and adolescents under 18 years of age is contraindicated, due to the lack of clinical efficacy and safety data.
APPLICATION IN ELDERLY PATIENTS

Pomalidomida change the dose in patients over 65 years of age is not required. For patients older than 75 years, initial dose of dexamethasone is 20 mg once per 1, 8, 15 and 22 day of each 28-day treatment cycle.
SPECIAL INSTRUCTIONS

Treatment with Imnovid ® should be started and be under the supervision of an experienced hematologist or chemotherapist.
Pregnancy prevention program
Strict adherence to all the requirements of the protection program of the pregnancy should be extended to all patients, if not reliably proven lack of child-bearing potential.
For women without childbearing potential:
A female patient or a woman, a sexual partner, a male patient, do not consider fertility in the presence of at least one of the following factors:
- age 50 years and duration of amenorrhea natural 1 year; *?
- early ovarian failure confirmed by a gynecologist;
- bilateral salpingooforektomiya hysterectomy or history;
- the XY genotype, Turner syndrome, uterine anatomic defect;
- amenorrhea due to anti-tumor therapy, or breast-feeding period and does not exclude the presence of child-bearing potential.
Counseling
Application pomalidomida in women with childbearing potential stored contraindicated if incorrect one of the following statement:
The woman should:
- understand the possibility of teratogenic effects on the fetus pomalidomida;
- understand the need for continued use effective contraception for 4 weeks before treatment, during treatment and 4 weeks after treatment pomalidomidom;
- even in the case of amenorrhea following all the rules of effective contraception;
- be able to comply with all rules of effective contraception;
- know and understand the possible consequences of pregnancy in patients receiving pomalidomida, as well as the need for urgent treatment advice for suspected a pregnancy;
- understand the need for compliance with all the rules of effective contraception in the background pomalidomida, the reception of which can start immediately after the negative results of the test for pregnancy;
- aware of the need for a test pa beremenioech and do it every 4 weeks;
- confirm that he understands the risks and necessary precautions associated with taking pomalidomida.
The physician should make sure that the woman saved childbearing potential:
- complies with all the terms of pregnancy prevention program, including an adequate level of understanding of its requirements;
- agreed to the above terms and conditions.
Application men
These pharmacokinetic study pomalidomida male volunteers indicate that pomalidomid may be contained in the seminal fluid of the patient. As a precaution, all men taking pomalidomid must comply with the following conditions:
A man must:
- understand the possible risk of teratogenic effects pomalidomida sexual contact with a pregnant woman or a woman of childbearing potential stored;
- the need to understand the use of condoms during sexual contact with a pregnant woman or a woman of childbearing potential stored not using reliable methods of contraception during treatment and for 7 days after the suspension and / or termination of treatment. Even after vasectomy man should use condom during sexual contact with a pregnant woman, as in the absence of sperm its seminal fluid may comprise pomalidomid;
- understand that if his partner becomes pregnant during his treatment pomalidomidom or within 7 days after discontinuation of therapy pomalidomidom, he should immediately inform your doctor, and his partner is recommended to consult a doctor, teratology for evaluation and advice.
contraception rules
Women with childbearing potential must be saved using one of the highly effective methods of contraception for 4 weeks before starting treatment, during treatment and for 4 weeks after treatment pomalidomidom even in case of a break in treatment. The exceptions are patients who for a long time completely abstain from sexual relations, as evidenced by a month. If the patient is not picked up by an effective contraceptive method, it should be sent to the gynecologist for the selection of a method of contraception and the beginning of its application.
Examples of highly effective methods of contraception include:
- Subcutaneous hormonal implants;
- intrauterine system releasing levonorgestrel;
- depot medroxyprogesterone acetate formulations;
- tubal ligation;
- sexual intercourse with a partner who had undergone vasectomy; vasectomy confirmed by two negative semen analyzes;
- progesterone-containing tablets which inhibit ovulation (e.g., desogestrel).
Admission COCs are not recommended to patients with multiple myeloma due to the increased risk of thromboembolic complications during treatment pomalidomidom and dexamethasone. If the patient uses a combination peroralpye contraceptives, it should be translated into one of the most effective contraceptive methods listed above. The increased risk of thromboembolism persists for 4-6 weeks after discontinuation of combined contraceptives. The efficacy of hormonal contraceptives may be reduced with concomitant administration of dexamethasone.
Subcutaneous hormonal implants or intrauterine system releasing levonorgestrel, are associated with an increased risk of infection at the time of installation and irregular vaginal bleeding. Patients with neutropenia who use these methods of contraception should be prophylactically prescribe antibiotics.
The use of intrauterine systems that produce copper, are generally not recommended due to the high risk of infection at the time of implantation and increased blood loss during menstruation, which can enhance the severity of neutropenia or thrombocytopenia.
Pregnancy tests
in accordance with accepted practices, pregnancy tests with a minimum sensitivity of 25 mIU / ml have prov
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