Lenalidomide (Capsules) Instructions for Use

Instructions
Dosage forms

ATC Code

L04AX04 (Lenalidomide)

Active Substance

Lenalidomide (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Immunomodulator with antiangiogenic properties

Pharmacotherapeutic Group

Immunosuppressants; other immunosuppressants

Pharmacological Action

Antineoplastic agent, immunomodulator, which possesses both immunomodulatory and antiangiogenic properties.

It inhibits the secretion of proinflammatory cytokines, including TNFα, interleukin-1β (IL-1β), IL-6, and IL-12, from lipopolysaccharide (LPS)-stimulated peripheral blood mononuclear cells (PBMC).

Lenalidomide increases the production of the anti-inflammatory cytokine IL-10 from LPS-stimulated PBMC, resulting in inhibition of expression, but not enzymatic activity, of COX-2.

Lenalidomide induces T-cell proliferation and increases the synthesis of IL-2 and interferon gamma-1, and also enhances the cytotoxic activity of natural killer cells.

Lenalidomide inhibits the proliferation of cells of various hematopoietic tumor lines, primarily those with cytogenetic defects of chromosome 5.

In a model of erythroid progenitor cell differentiation, Lenalidomide induces fetal hemoglobin expression, as judged by the differentiation of CD34⁺ hematopoietic stem cells.

Lenalidomide inhibits angiogenesis by blocking microvessel and endothelial tubule formation, as well as endothelial cell migration in an in vitro angiogenesis model. Furthermore, Lenalidomide inhibits the synthesis of the proangiogenic vascular endothelial growth factor by PC-3 prostate tumor cells.

Pharmacokinetics

Lenalidomide is a racemic mixture of two optically active forms: S(-) and R(+) with a net optical rotation of zero.

After oral administration, Lenalidomide is rapidly absorbed. C_max is achieved within 0.625-1.5 hours after a single dose. Food intake does not affect the extent of absorption. The pharmacokinetic distribution is linear. C_max and AUC increase proportionally with increasing dose. Repeated administration of the drug does not lead to its accumulation.

In patients with multiple myeloma, Lenalidomide is rapidly absorbed, with C_max achieved within 0.5-4 hours after administration, both on day 1 and on day 28. C_max and AUC increase proportionally with both single and repeated administration of the drug. According to C_max and AUC data, lenalidomide exposure in patients with multiple myeloma is higher than in healthy volunteers, which is explained by a lower clearance to filtration ratio (CL/F) in patients with multiple myeloma compared to healthy volunteers, 300 and 200 ml/min, respectively.

In vitro binding of (¹⁴C)-lenalidomide to plasma proteins in patients with multiple myeloma and healthy volunteers was 22.7% and 29.2%, respectively.

Approximately 60% of lenalidomide is excreted by the kidneys unchanged. This exceeds the glomerular filtration rate and, therefore, the process is both passive and active. T_1/2 increases with increasing dose, from approximately 3 hours at a dose of 5 mg to approximately 9 hours at a dose of 400 mg. Steady state is reached on day 4.

C_max does not differ between patients with normal and impaired renal function. However, the elimination of lenalidomide slows down proportionally to the degree of renal impairment. A decrease in CrCl to less than 50 ml/min is accompanied by a 56% increase in AUC. The T_1/2 of lenalidomide increases from approximately 3.5 hours (in patients with CrCl greater than 50 ml/min) to approximately 9 hours (in patients with CrCl less than 50 ml/min).

Indications

Treatment of multiple myeloma – in combination with dexamethasone in patients who have received at least one prior therapy.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
C90.0	Multiple myeloma

ICD-11 code	Indication
2A83.1	Plasma cell myeloma

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Capsules

Take orally.

The recommended initial dose is 25 mg once daily on days 1-21 of repeated 28-day cycles. Dexamethasone at a dose of 40 mg is administered once daily on days 1-4, 9-12, and 17-20 of each 28-day cycle during the first 4 therapy cycles, and then at 40 mg once daily on days 1-4 of each subsequent 28-day cycle.

If toxic effects develop, the dosage regimen is adjusted according to a specific scheme.

In patients with impaired renal function, dosage regimen adjustment is required.

Adverse Reactions

Most frequently with the use of the Lenalidomide/dexamethasone combination: neutropenia (39.4%), muscle weakness (27.2%), asthenia (17.6%), constipation (23.5%), muscle cramps (20.1%), thrombocytopenia (18.4%), anemia (17%), diarrhea (14.2%), rash (10.2%).

Most serious adverse reactions: venous thromboembolism (deep vein thrombosis, pulmonary embolism), grade 4 neutropenia.

From the hematopoietic system: very common – neutropenia, thrombocytopenia, anemia; common – leukopenia, lymphopenia.

From the cardiovascular system: common – deep vein thrombosis, decreased blood pressure.

Infections and infestations: common – pneumonia.

From the musculoskeletal system: very common – muscle cramps.

From the nervous system: common – tremor, hypesthesia.

From the respiratory system: common – dyspnea (including exertional dyspnea).

From the skin and subcutaneous tissue: very common – skin rash; common – skin itching.

General reactions: very common – weakness, asthenia.

Contraindications

Pregnancy; lactation (breastfeeding); childbearing potential; inability to comply with necessary contraceptive measures; childhood; hypersensitivity to lenalidomide.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

Lenalidomide is a structural analogue of thalidomide, which has a pronounced teratogenic effect. It is known that the use of thalidomide by pregnant women causes severe and life-threatening malformations of the internal organs of the fetus (with a frequency of up to 30%). Experimental studies in monkeys showed results similar to those previously described for thalidomide. The risk of developing congenital defects is very high if Lenalidomide is used during pregnancy.

Strict adherence to contraception applies to both women and men.

Special Precautions

For the prevention of venous thromboembolism, especially in patients with additional risk factors, the use of low molecular weight heparins or warfarin is recommended. The decision to prescribe antithrombotic therapy should be made after a thorough assessment of individual risk factors.

The risk of developing grade 4 neutropenia in patients with multiple myeloma with the simultaneous use of lenalidomide and dexamethasone is very high.

Careful monitoring by both the doctor and the patient for symptoms of increased bleeding, including petechiae and hemoptysis, is recommended.

During the first 2 months of lenalidomide treatment, a complete blood count, including white blood cell count, differential, platelet count, hemoglobin, and hematocrit, should be performed weekly. Subsequently, blood tests should be performed monthly.

The manifestations of lenalidomide toxicity that most often limit its use are neutropenia and thrombocytopenia. In this regard, the decision to use lenalidomide concomitantly with other immunosuppressive drugs must be clinically justified.

Given the predominant excretion of lenalidomide by the kidneys, in patients with renal insufficiency, renal function and the dose of lenalidomide must be carefully monitored.

Regular monitoring of thyroid function is necessary due to the possibility of hypothyroidism developing under the influence of lenalidomide.

The possibility of neurotoxic effects of lenalidomide with long-term use cannot be ruled out, given the structural similarity of the molecules of lenalidomide and thalidomide, which is known for its pronounced neurotoxic side effect.

Due to the pronounced antineoplastic activity of lenalidomide, tumor lysis syndrome may develop, especially in patients with a high tumor burden. Such patients should be monitored and appropriate prophylaxis should be administered.

Patients are not allowed to donate blood or sperm as a donor throughout the treatment with lenalidomide and for one week after its completion.

Effect on ability to drive vehicles and operate machinery

Some side effects of lenalidomide, such as dizziness, weakness, drowsiness, and blurred vision, may adversely affect the ability to drive a car and perform potentially hazardous activities requiring increased concentration and speed of psychomotor reactions. In this regard, special caution should be exercised when driving vehicles and operating machinery.

Drug Interactions

Mutual influence on the metabolism of lenalidomide and other drugs is unlikely because Lenalidomide is not metabolized by the cytochrome P450 system.

Concomitant administration of lenalidomide with digoxin is accompanied by an increase in the plasma concentration of digoxin (C_max of digoxin was 114%, AUC – 108%). Thus, during treatment with lenalidomide, it is recommended to monitor the concentration of digoxin.

Dexamethasone, which is a mandatory component of the therapeutic regimen with lenalidomide, may reduce the effectiveness of oral contraceptives.

No mutual influence on the pharmacokinetic parameters of lenalidomide and warfarin was noted. However, given the use of dexamethasone in combination with lenalidomide, the influence of the former on the effects of warfarin cannot be excluded. Therefore, during combined therapy with lenalidomide and dexamethasone, careful monitoring of the warfarin concentration is recommended.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Lenalidomide [Hetero Labs, Limited (India)]
Capsules 5 mg: 10, 20, 21, 28, 30, 60, or 100 pcs.
Capsules 10 mg: 10, 20, 21, 28, 30, 60, or 100 pcs.
Capsules 15 mg: 10, 20, 21, 28, 30, 60, or 100 pcs.
Capsules 25 mg: 10, 20, 21, 28, 30, 60, or 100 pcs.

Marketing Authorization Holder

Hetero Labs, Limited (India)

Dosage Forms

	Lenalidomide	Capsules 5 mg: 10, 20, 21, 28, 30, 60, or 100 pcs.
		Capsules 10 mg: 10, 20, 21, 28, 30, 60, or 100 pcs.
		Capsules 15 mg: 10, 20, 21, 28, 30, 60, or 100 pcs.
		Capsules 25 mg: 10, 20, 21, 28, 30, 60, or 100 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin opaque (size 2) white, with black marking: “H” on the cap and “L2” on the body.
Capsule contents – powder from grayish-white to pale yellow.

	1 caps.
Lenalidomide (Lenalidomide form-H1)	5 mg

Excipients: lactose – 40 mg, microcrystalline cellulose (type 112) – 32.6 mg, croscarmellose sodium – 1.6 mg, magnesium stearate – 0.8 mg.

Capsule shell (gelatin, purified water, titanium dioxide, black ink “TekPrint^TMSW-9008″ *) – 63 mg.

*Black ink “TekPrint^TMSW-9008″ for printing on the capsule: shellac, ethanol, isopropanol, butanol, propylene glycol, aqueous ammonia, black iron oxide dye, potassium hydroxide, purified water.

10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (6) – cardboard packs.
21 pcs. – bottle (1) – cardboard packs.
28 pcs. – bottle (1) – cardboard packs.
100 pcs. – bottle (1) – cardboard packs.

Capsules hard gelatin (size 0), opaque orange cap with black marking “H”, opaque white body with black marking “L4”.
Capsule contents – powder from grayish-white to pale yellow.

	1 caps.
Lenalidomide (Lenalidomide form-H1)	10 mg

Excipients: lactose – 80 mg, microcrystalline cellulose (type 112) – 65.2 mg, croscarmellose sodium – 3.2 mg, magnesium stearate – 1.6 mg.

Capsule shell (body – gelatin, purified water, titanium dioxide, black ink “TekPrint^TMSW-9008″*; cap – gelatin, purified water, titanium dioxide, “sunset yellow” dye (“FD&C yellow No. 6”), black ink “TekPrint^TMSW-9008″*) – 96 mg.

*Black ink “TekPrint^TMSW-9008″ for printing on the capsule: shellac, ethanol, isopropanol, butanol, propylene glycol, aqueous ammonia, black iron oxide dye, potassium hydroxide, purified water.

10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (6) – cardboard packs.
21 pcs. – bottles (1) – cardboard packs.
28 pcs. – bottles (1) – cardboard packs.
100 pcs. – bottles (1) – cardboard packs.

Capsules hard gelatin (size 0), opaque reddish-brown cap with black marking “H”, opaque white body with black marking “L5”.
Capsule contents – powder from grayish-white to pale yellow.

	1 caps.
Lenalidomide (Lenalidomide form-H1)	15 mg

Excipients: lactose – 120 mg, microcrystalline cellulose (type 112) – 97.8 mg, croscarmellose sodium – 4.8 mg, magnesium stearate – 2.4 mg.

Capsule shell (body – gelatin, purified water, titanium dioxide, black ink “TekPrint^TMSW-9008″*; cap – gelatin, purified water, titanium dioxide, red iron oxide dye, black ink “TekPrint^TMSW-9008″*) – 96 mg.

*Black ink “TekPrint^TMSW-9008″ for printing on the capsule: shellac, ethanol, isopropanol, butanol, propylene glycol, aqueous ammonia, black iron oxide dye, potassium hydroxide, purified water.

Capsules hard gelatin opaque (size 0) white, with black marking: “H” on the cap and “L7” on the body.
Capsule contents – powder from grayish-white to pale yellow.

	1 caps.
Lenalidomide (Lenalidomide form H1)	25 mg

Excipients: lactose – 200 mg, microcrystalline cellulose (type 112) – 163 mg, croscarmellose sodium – 8 mg, magnesium stearate – 4 mg.

Capsule shell (gelatin, purified water, titanium dioxide, black ink “TekPrint^TMSW-9008″*) – 96 mg.

*Black ink “TekPrint^TMSW-9008″ for printing on the capsule: shellac, ethanol, isopropanol, butanol, propylene glycol, aqueous ammonia, black iron oxide dye, potassium hydroxide, purified water.

Lenalidomide [Nanopharma Development, LLC (Russia)]
Capsules 2.5 mg: 7, 10, 14, 20, 21, 28, 30, 40, 42, or 60 pcs.
Capsules 5 mg: 7, 10, 14, 20, 21, 28, 30, 40, 42, or 60 pcs.
Capsules 7.5 mg: 7, 10, 14, 20, 21, 28, 30, 40, 42, or 60 pcs.
Capsules 10 mg: 7, 10, 14, 20, 21, 28, 30, 40, 42, or 60 pcs.
Capsules 15 mg: 7, 10, 14, 20, 21, 28, 30, 40, 42, or 60 pcs.
Capsules 20 mg: 7, 10, 14, 20, 21, 28, 30, 40, 42, or 60 pcs.
Capsules 25 mg: 7, 10, 14, 20, 21, 28, 30, 40, 42 or 60 pcs.

Marketing Authorization Holder

Nanopharma Development, LLC (Russia)

Manufactured By

Nanopharma Development, LLC (Russia)

Primary Packaging

NANOPHARMA DEVELOPMENT, LLC (Russia)

Secondary Packaging

NANOPHARMA DEVELOPMENT, LLC (Russia)

IZVARINO PHARMA, LLC (Russia)

Quality Control Release

NANOPHARMA DEVELOPMENT, LLC (Russia)

IZVARINO PHARMA, LLC (Russia)

Dosage Forms

	Lenalidomide	Capsules 2.5 mg: 7, 10, 14, 20, 21, 28, 30, 40, 42, or 60 pcs.
		Capsules 5 mg: 7, 10, 14, 20, 21, 28, 30, 40, 42, or 60 pcs.
		Capsules 7.5 mg: 7, 10, 14, 20, 21, 28, 30, 40, 42, or 60 pcs.
		Capsules 10 mg: 7, 10, 14, 20, 21, 28, 30, 40, 42, or 60 pcs.
		Capsules 15 mg: 7, 10, 14, 20, 21, 28, 30, 40, 42, or 60 pcs.
		Capsules 20 mg: 7, 10, 14, 20, 21, 28, 30, 40, 42, or 60 pcs.
		Capsules 25 mg: 7, 10, 14, 20, 21, 28, 30, 40, 42 or 60 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin size No. 4, opaque body and cap, from white or almost white to white with a yellowish tint; capsule contents – a powdery mass (its compaction is allowed) from white or almost white to white with a yellowish tint.

	1 caps.
Lenalidomide	2.5 mg

Excipients: mannitol, microcrystalline cellulose (type 112), croscarmellose sodium, magnesium stearate.

Capsule shell composition: titanium dioxide, gelatin.

7 pcs. – blister packs (1) – cardboard packs.
7 pcs. – blister packs (2) – cardboard packs.
7 pcs. – blister packs (3) – cardboard packs.
7 pcs. – blister packs (4) – cardboard packs.
7 pcs. – blister packs (6) – cardboard packs.
10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (4) – cardboard packs.
10 pcs. – blister packs (6) – cardboard packs.

Capsules hard gelatin size No. 2, opaque body and cap, from white or almost white to white with a yellowish tint; capsule contents – a powdery mass (its compaction is allowed) from white or almost white to white with a yellowish tint.

	1 caps.
Lenalidomide	5 mg

Excipients: mannitol, microcrystalline cellulose (type 112), croscarmellose sodium, magnesium stearate.

Capsule shell composition: titanium dioxide, gelatin.

Capsules hard gelatin size No. 3, opaque body and cap, from white or almost white to white with a yellowish tint; capsule contents – a powdery mass (its compaction is allowed) from white or almost white to white with a yellowish tint.

	1 caps.
Lenalidomide	7.5 mg

Excipients: mannitol, microcrystalline cellulose (type 112), croscarmellose sodium, magnesium stearate.

Capsule shell composition: titanium dioxide, gelatin.

	1 caps.
Lenalidomide	10 mg

Excipients: mannitol, microcrystalline cellulose (type 112), croscarmellose sodium, magnesium stearate.

Capsule shell composition: titanium dioxide, gelatin.

Capsules hard gelatin size No. 1, opaque body and cap, from white or almost white to white with a yellowish tint; capsule contents – a powdery mass (its compaction is allowed) from white or almost white to white with a yellowish tint.

	1 caps.
Lenalidomide	15 mg

Excipients: mannitol, microcrystalline cellulose (type 112), croscarmellose sodium, magnesium stearate.

Capsule shell composition: titanium dioxide, gelatin.

Capsules hard gelatin size No. 0, opaque body and cap, from white or almost white to white with a yellowish tint; capsule contents – a powdery mass (its compaction is allowed) from white or almost white to white with a yellowish tint.

	1 caps.
Lenalidomide	20 mg

Excipients: mannitol, microcrystalline cellulose (type 112), croscarmellose sodium, magnesium stearate.

Capsule shell composition: titanium dioxide, gelatin.

	1 caps.
Lenalidomide	25 mg

Excipients: mannitol, microcrystalline cellulose (type 112), croscarmellose sodium, magnesium stearate.

Capsule shell composition: titanium dioxide, gelatin.

Lenalidomide [Ozon Medica, LLC (Russia)]
Capsules 5 mg: 4, 7, 8, 10, 12, 14, 20, 21, 24, 28, 30, 40, 42, 49, 56, 70, 98, 100, or 140 pcs.
Capsules 10 mg: 4, 7, 8, 10, 12, 14, 20, 21, 24, 28, 30, 40, 42, 49, 56, 70, 98, 100, or 140 pcs.
Capsules 15 mg: 4, 7, 8, 10, 12, 14, 20, 21, 24, 28, 30, 40, 42, 49, 56, 70, 98, 100, or 140 pcs.
Capsules 25 mg: 4, 7, 8, 10, 12, 14, 20, 21, 24, 28, 30, 40, 42, 49, 56, 70, 98, 100, or 140 pcs.

Marketing Authorization Holder

Ozon Medica, LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Forms

	Lenalidomide	Capsules 5 mg: 4, 7, 8, 10, 12, 14, 20, 21, 24, 28, 30, 40, 42, 49, 56, 70, 98, 100, or 140 pcs.
		Capsules 10 mg: 4, 7, 8, 10, 12, 14, 20, 21, 24, 28, 30, 40, 42, 49, 56, 70, 98, 100, or 140 pcs.
		Capsules 15 mg: 4, 7, 8, 10, 12, 14, 20, 21, 24, 28, 30, 40, 42, 49, 56, 70, 98, 100, or 140 pcs.
		Capsules 25 mg: 4, 7, 8, 10, 12, 14, 20, 21, 24, 28, 30, 40, 42, 49, 56, 70, 98, 100, or 140 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin size No. 2, opaque, white body and cap; capsule contents – powder from white to white with a yellowish tint; compaction of the capsule contents into lumps is allowed, which should crumble upon light pressure with a glass rod.

	1 caps.
Lenalidomide*	5 mg

* lenalidomide hemihydrate calculated as Lenalidomide; depending on the actual content of the active substance in the substance, the calculation is performed for each batch of the drug, compensating for the change in the content of the active substance by a corresponding change in the content of lactose monohydrate.

Excipients: lactose monohydrate (milk sugar) – 147 mg, microcrystalline cellulose (MCC 102) – 40 mg, croscarmellose sodium – 6 mg, magnesium stearate – 2 mg.

Capsule body composition: titanium dioxide – 2%, gelatin – up to 100%.
Capsule cap composition: titanium dioxide – 2%, gelatin – up to 100%.

4 pcs. – blister packs (from 1 to 10 pcs.) – cardboard packs.
7 pcs. – blister packs (from 1 to 10 pcs.) – cardboard packs.
10 pcs. – blister packs (from 1 to 10 pcs.) – cardboard packs.
14 pcs. – blister packs (from 1 to 10 pcs.) – cardboard packs.

Capsules hard gelatin size No. 0, opaque, light yellow body with a brown tint, light purple cap; capsule contents – powder from white to white with a yellowish tint; compaction of the capsule contents into lumps is allowed, which should crumble upon light pressure with a glass rod.

	1 caps.
Lenalidomide*	10 mg

Excipients: lactose monohydrate (milk sugar) – 294 mg, microcrystalline cellulose (MCC 102) – 80 mg, croscarmellose sodium – 12 mg, magnesium stearate – 4 mg.

Capsule body composition: iron oxide yellow – 0.1227%, iron oxide red – 0.0071%, titanium dioxide – 2%, gelatin – up to 100%.
Capsule cap composition: brilliant blue – 0.0190%, allura red – 0.045%, titanium dioxide – 3%, gelatin – up to 100%.

Capsules hard gelatin size No. 0, opaque, white body, blue cap; capsule contents – powder from white to white with a yellowish tint; compaction of the capsule contents into lumps is allowed, which should crumble upon light pressure with a glass rod.

	1 caps.
Lenalidomide*	15 mg

Excipients: lactose monohydrate (milk sugar) – 289 mg, microcrystalline cellulose (MCC 102) – 80 mg, croscarmellose sodium – 12 mg, magnesium stearate – 4 mg.

Capsule body composition: titanium dioxide – 2%, gelatin – up to 100%.
Capsule cap composition: azorubine – 0.0821%, brilliant black – 0.1533%, ponceau 4R – 0.0192%, patent blue – 0.1314%, titanium dioxide – 2%, gelatin – up to 100%.

Capsules hard gelatin size No. 0, opaque, white body and cap; capsule contents – powder from white to white with a yellowish tint; compaction of the capsule contents into lumps is allowed, which should crumble upon light pressure with a glass rod.

	1 caps.
Lenalidomide*	25 mg

Excipients: lactose monohydrate (milk sugar) – 200 mg, microcrystalline cellulose (MCC 102) – 159 mg, croscarmellose sodium – 12 mg, magnesium stearate – 4 mg.

Capsule body composition: titanium dioxide – 2%, gelatin – up to 100%.
Capsule cap composition: titanium dioxide – 2%, gelatin – up to 100%.

Lenalidomide [Pharmasintez, JSC (Russia)]
Capsules 5 mg: 7 or 21 pcs.
Capsules 10 mg: 7 or 21 pcs.
Capsules 15 mg: 7 or 21 pcs.
Capsules 25 mg: 7 or 21 pcs.

Marketing Authorization Holder

Pharmasintez, JSC (Russia)

Dosage Forms

	Lenalidomide	Capsules 5 mg: 7 or 21 pcs.
		Capsules 10 mg: 7 or 21 pcs.
		Capsules 15 mg: 7 or 21 pcs.
		Capsules 25 mg: 7 or 21 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin size No. 3, white body, white cap.

	1 caps.
Lenalidomide	5 mg

Excipients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, croscarmellose sodium, microcrystalline cellulose.

Capsule shell purified water, sodium lauryl sulfate, titanium dioxide, gelatin.

7 pcs. – blister packs (1) – cardboard packs.
7 pcs. – blister packs (3) – cardboard packs.
7 pcs. – jars (1) – cardboard packs.
21 pcs. – jars (1) – cardboard packs.

Capsules hard gelatin size No. 2, blue body, blue cap.

	1 caps.
Lenalidomide	10 mg

Excipients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, croscarmellose sodium, microcrystalline cellulose.

Capsule shell purified water, sodium lauryl sulfate, titanium dioxide, brilliant blue, gelatin.
7 pcs. – blister packs (1) – cardboard packs.
7 pcs. – blister packs (3) – cardboard packs.
7 pcs. – jars (1) – cardboard packs.
21 pcs. – jars (1) – cardboard packs.

Capsules hard gelatin size No. 1, white body, red cap.

	1 caps.
Lenalidomide	15 mg

Excipients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, croscarmellose sodium, microcrystalline cellulose.

Capsule shell purified water, sodium lauryl sulfate, titanium dioxide, gelatin, ponceau 4R, sunset yellow.

7 pcs. – blister packs (1) – cardboard packs.
7 pcs. – blister packs (3) – cardboard packs.
7 pcs. – jars (1) – cardboard packs.
21 pcs. – jars (1) – cardboard packs.

Capsules hard gelatin size No. 0, white body, white cap.

	1 caps.
Lenalidomide	25 mg

Excipients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, croscarmellose sodium, microcrystalline cellulose.

Capsule shell purified water, sodium lauryl sulfate, titanium dioxide, gelatin.

7 pcs. – blister packs (1) – cardboard packs.
7 pcs. – blister packs (3) – cardboard packs.
7 pcs. – jars (1) – cardboard packs.
21 pcs. – jars (1) – cardboard packs.

Lenalidomide Canon [Canonpharma Production, CJS (Russia)]
Capsules 2.5 mg: 21 pcs.
Capsules 5 mg: 21 pcs.
Capsules 7.5 mg: 21 pcs.
Capsules 10 mg: 21 pcs.
Capsules 15 mg: 21 pcs.
Capsules 20 mg: 21 pcs.
Capsules 25 mg: 21 pcs.

Marketing Authorization Holder

Canonpharma Production, CJS (Russia)

Dosage Forms

	Lenalidomide Canon	Capsules 2.5 mg: 21 pcs.
		Capsules 5 mg: 21 pcs.
		Capsules 7.5 mg: 21 pcs.
		Capsules 10 mg: 21 pcs.
		Capsules 15 mg: 21 pcs.
		Capsules 20 mg: 21 pcs.
		Capsules 25 mg: 21 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin size #3, with a blue body and cap; capsule contents are a powder ranging from almost white to pale yellow.

	1 caps.
Lenalidomide	2.5 mg

Excipients: colloidal silicon dioxide – 0.5 mg, croscarmellose sodium – 2.5 mg, lactose monohydrate – 73.5 mg, magnesium stearate – 1 mg, microcrystalline cellulose (type 102) – 20 mg.

Hard gelatin capsule:
Body gelatin – 28.2043 mg, titanium dioxide – 0.576 mg, indigo carmine dye – 0.0197 mg;
Cap gelatin – 18.8029 mg, titanium dioxide – 0.384 mg, indigo carmine dye – 0.0131 mg.

7 pcs. – blister packs (3) – cardboard packs.

Capsules hard gelatin size #3, with a white body and cap; capsule contents are a powder ranging from almost white to pale yellow.

	1 caps.
Lenalidomide	5 mg

Excipients: colloidal silicon dioxide – 0.7 mg, croscarmellose sodium – 4.5 mg, lactose monohydrate – 108.3 mg, magnesium stearate – 1.5 mg, microcrystalline cellulose (type 102) – 30 mg.

Hard gelatin capsule:
Body gelatin – 28.224 mg, titanium dioxide – 0.576 mg;
Cap gelatin – 18.816 mg, titanium dioxide – 0.384 mg.

7 pcs. – blister packs (3) – cardboard packs.

Capsules hard gelatin size #2, with a blue body and cap; capsule contents are a powder ranging from almost white to pale yellow.

	1 caps.
Lenalidomide	7.5 mg

Excipients: colloidal silicon dioxide – 1 mg, croscarmellose sodium – 6 mg, lactose monohydrate – 143.5 mg, magnesium stearate – 2 mg, microcrystalline cellulose (type 102) – 40 mg.

Hard gelatin capsule:
Body gelatin – 35.766 mg, titanium dioxide – 0.732 mg, patent blue V dye – 0.102 mg;
Cap: gelatin – 23.844 mg, titanium dioxide – 0.488 mg, patent blue V dye – 0.068 mg.

7 pcs. – blister packs (3) – cardboard packs.

Capsules hard gelatin size #1, with a pale yellow body and blue cap; capsule contents are a powder ranging from almost white to pale yellow.

	1 caps.
Lenalidomide	10 mg

Excipients: colloidal silicon dioxide – 1.2 mg, croscarmellose sodium – 7.5 mg, lactose monohydrate – 178.8 mg, magnesium stearate – 2.5 mg, microcrystalline cellulose (type 102) – 50 mg.

Hard gelatin capsule:
Body gelatin – 45.0555 mg, titanium dioxide – 0.4614 mg, yellow iron oxide dye – 0.083 mg;
Cap gelatin – 29.6127 mg, titanium dioxide – 0.7296 mg, red iron oxide dye – 0.0486 mg, brilliant blue FCF dye – 0.0091 mg.

7 pcs. – blister packs (3) – cardboard packs.

Capsules hard gelatin size #1, with a white body and blue cap; capsule contents are a powder ranging from almost white to pale yellow.

	1 caps.
Lenalidomide	15 mg

Excipients: colloidal silicon dioxide – 1.5 mg, croscarmellose sodium – 9 mg, lactose monohydrate – 211.5 mg, magnesium stearate – 3 mg, microcrystalline cellulose (type 102) – 60 mg.

Hard gelatin capsule:
Body gelatin – 44.688 mg, titanium dioxide – 0.912 mg;
Cap gelatin – 29.4482 mg, titanium dioxide – 0.912 mg, indigo carmine dye – 0.0183 mg, yellow iron oxide dye – 0.0215 mg.

7 pcs. – blister packs (3) – cardboard packs.

Capsules hard gelatin size #0, with a blue body and cap; capsule contents are a powder ranging from almost white to pale yellow.

	1 caps.
Lenalidomide	20 mg

Excipients: colloidal silicon dioxide – 1.8 mg, croscarmellose sodium – 10.5 mg, lactose monohydrate – 224.2 mg, magnesium stearate – 3.5 mg, microcrystalline cellulose (type 102) – 70 mg.

Hard gelatin capsule:
Body gelatin – 55.7965 mg, titanium dioxide – 1.728 mg, indigo carmine dye, yellow iron oxide dye – 0.0408 mg;
Cap gelatin – 37.1977 mg, titanium dioxide – 1.1520 mg, indigo carmine dye – 0.0231 mg, yellow iron oxide dye – 0.0272 mg.

7 pcs. – blister packs (3) – cardboard packs.

Capsules hard gelatin size #0, with a white body and cap; capsule contents are a powder ranging from almost white to pale yellow.

	1 caps.
Lenalidomide	25 mg

Excipients: colloidal silicon dioxide – 1.8 mg, croscarmellose sodium – 12 mg, lactose monohydrate – 237.7 mg, magnesium stearate – 3.5 mg, microcrystalline cellulose (type 102) – 70 mg.

Hard gelatin capsule:
Body gelatin – 56.448 mg, titanium dioxide – 1.152 mg;
Cap gelatin – 37.632 mg, titanium dioxide – 0.768 mg.

7 pcs. – blister packs (3) – cardboard packs.

	1 capsule
Lenalidomide hydrochloride monohydrate	30.27 mg,
Equivalent to lenalidomide content	25 mg

Excipients: mannitol, microcrystalline cellulose type 102, pregelatinized starch, tartaric acid.

Capsule body: iron oxide red (E172), iron oxide black (E172), iron oxide yellow (E172), titanium dioxide (E171), carrageenan, potassium chloride, purified water, hypromellose 2910.
Capsule cap: iron oxide red (E172), iron oxide black (E172), iron oxide yellow (E172), titanium dioxide (E171), carrageenan, potassium chloride, purified water, hypromellose 2910.

21 pcs. – bottles – carton packs.

Lenalidomide-Nativ [Nativa, LLC (Russia)]
Capsules 2.5 mg: 21 pcs.
Capsules 5 mg: 21 pcs.
Capsules 7.5 mg: 21 pcs.
Capsules 10 mg: 21 pcs.
Capsules 15 mg: 21 pcs.
Capsules 20 mg: 21 pcs.
Capsules 25 mg: 21 pcs.

Marketing Authorization Holder

Nativa, LLC (Russia)

Dosage Forms

	Lenalidomide-Nativ	Capsules 2.5 mg: 21 pcs.
		Capsules 5 mg: 21 pcs.
		Capsules 7.5 mg: 21 pcs.
		Capsules 10 mg: 21 pcs.
		Capsules 15 mg: 21 pcs.
		Capsules 20 mg: 21 pcs.
		Capsules 25 mg: 21 pcs.

Dosage Form, Packaging, and Composition

Capsules hard, gelatin, size #4; white body, red cap.

	1 capsule
Lenalidomide	2.5 mg

Excipients: lactose monohydrate – 73.5 mg, microcrystalline cellulose – 20 mg, croscarmellose sodium – 3 mg, magnesium stearate – 1 mg.

Composition of capsule body: gelatin – up to 100 mg, titanium dioxide – 2 mg.
Composition of capsule cap: gelatin – up to 100 mg, titanium dioxide – 0.5 mg, iron oxide yellow – 0.45 mg, iron oxide red – 0.2 mg, azorubine (E122) – 0.14 mg.