• Regardless of attribution of relatedness to POMALYST.
  a POMALYST alone arm includes all patients randomized to the POMALYST alone arm who took study drug; 61 of the 107 patients had dexamethasone added during the treatment period.
  b Serious adverse reactions were reported in at least 2 patients in any POMALYST treatment arm.
  Data cutoff: 01 March 2013

All Adverse Reactions ≥10% in Either Arm

Grade 3 or 4 ≥5% in Either Arm

Body System
Adverse Reaction

POMALYSTa
** (N=107)**

POMALYST + Low-dose Dex
(N=112)

POMALYST
(N=107)

POMALYST + Low-dose Dex
(N=112)

Number (%) of patients with at least one adverse reaction

107 (100)

112 (100)

98 (92)

102 (91)

** Blood and lymphatic system disorders**

Neutropenia b

57 (53)

55 (49)

51 (48)

46 (41)

Anemia b

41 (38)

47 (42)

25 (23)

24 (21)

Thrombocytopenia b

28 (26)

26 (23)

24 (22)

21 (19)

Leukopenia

14 (13)

22 (20)

7 (7)

11 (10)

Febrile neutropenia b

<10%

<10%

6 (6)

3 (3)

Lymphopenia

4 (4)

17 (15)

2 (2)

8 (7)

** General disorders and administration site conditions**

Fatigue and asthenia b

62 (58)

70 (63)

13 (12)

19 (17)

Edema peripheral

27 (25)

19 (17)

0 (0.0)

0 (0.0)

Pyrexia b

25 (23)

36 (32)

<5%

<5%

Chills

11 (10)

14 (13)

0 (0.0)

0 (0.0)

** Gastrointestinal disorders**

Nausea b

39 (36)

27 (24)

<5%

<5%

Constipation b

38 (36)

41 (37)

<5%

<5%

Diarrhea

37 (35)

40 (36)

<5%

<5%

Vomiting b

15 (14)

16 (14)

<5%

0 (0.0)

** Musculoskeletal and connective tissue disorders**

Back pain b

37 (35)

36 (32)

15 (14)

11 (10)

Musculoskeletal chest pain

25 (23)

22 (20)

<5%

0 (0.0)

Muscle spasms

23 (21)

22 (20)

<5%

<5%

Arthralgia

18 (17)

17 (15)

<5%

<5%

Muscular weakness

15 (14)

15 (13)

6 (6)

4 (4)

Bone pain

13 (12)

8 (7)

<5%

<5%

Musculoskeletal pain

13 (12)

19 (17)

<5%

<5%

Pain in extremity

8 (7)

16 (14)

0 (0.0)

<5%

** Infections and infestations**

Upper respiratory tract infection

40 (37)

32 (29)

<5%

<5%

Pneumonia b

30 (28)

38 (34)

21 (20)

32 (29)

Urinary tract infection b

11 (10)

19 (17)

2 (2)

10 (9)

Sepsis b

<10%

<10%

6 (6)

5 (4)

** Metabolism and nutrition disorders**

Decreased appetite

25 (23)

21 (19)

<5%

0 (0.0)

Hypercalcemia b

23 (21)

13 (12)

11 (10)

1 (<1)

Hypokalemia

13 (12)

13 (12)

<5%

<5%

Hyperglycemia

12 (11)

17 (15)

<5%

<5%

Hyponatremia

12 (11)

14 (13)

<5%

<5%

Dehydration b

<10%

<10%

5 (4.7)

6 (5.4)

Hypocalcemia

6 (6)

13 (12)

0 (0.0)

<5%

** Respiratory, thoracic and mediastinal disorders**

Dyspnea b

38 (36)

50 (45)

8 (7)

14 (13)

Cough

18 (17)

25 (22)

0 (0.0)

0 (0.0)

Epistaxis

18 (17)

12 (11)

<5%

0 (0.0)

Productive cough

10 (9)

14 (13)

0 (0.0)

0 (0.0)

Oropharyngeal pain

6 (6)

12 (11)

0 (0.0)

0 (0.0)

** Nervous system disorders**

Dizziness

24 (22)

20 (18)

<5%

<5%

Peripheral neuropathy

23 (21)

20 (18)

0 (0.0)

0 (0.0)

Headache

16 (15)

15 (13)

0 (0.0)

<5%

Tremor

11 (10)

15 (13)

0 (0.0)

0 (0.0)

** Skin and subcutaneous tissue disorders**

Rash

22 (21)

18 (16)

0 (0.0)

<5%

Pruritus

16 (15)

10 (9)

0 (0.0)

0 (0.0)

Dry skin

10 (9)

12 (11)

0 (0.0)

0 (0.0)

Hyperhidrosis

8 (7)

18 (16)

0 (0.0)

0 (0.0)

Night sweats

5 (5)

14 (13)

0 (0.0)

0 (0.0)

** Investigations**

Blood creatinine increased b

20 (19)

11 (10)

6 (6)

3 (3)

Weight decreased

16 (15)

10 (9)

0 (0.0)

0 (0.0)

Weight increased

1 (<1)

12 (11)

0 (0.0)

0 (0.0)

** Psychiatric disorders**

Anxiety

14 (13)

8 (7)

0 (0.0)

0 (0.0)

Confusional state b

13 (12)

15 (13)

6 (6)

3 (3)

Insomnia

7 (7)

18 (16)

0 (0.0)

0 (0.0)

** Renal and urinary disorders**

Renal failure b

16 (15)

11 (10)

9 (8)

8 (7)

a Percentage did not meet the criteria to be considered as an adverse reaction for POMALYST for that category of event (i.e., all adverse events or Grade 3 or 4 adverse events).
b Serious adverse reactions were reported in at least 3 patients in the POM + Low-dose Dex arm, AND at least 1% higher than the High-dose-Dex arm percentage.
Data cutoff: 01 March 2013

All Adverse Reactions
** (≥5% in POMALYST + Low-dose Dex arm, and at least 2% higher than the High- dose-Dex arm)**

Grade 3 or 4
(≥1% in POMALYST + Low-dose Dex arm, and at least 1% higher than the High- dose-Dex arm)

Body System
Adverse Reaction

POMALYST + Low-dose Dex
(N=300)

High-dose Dex
(N=150)

POMALYST + Low-dose Dex
** (N=300)**

High-dose Dex
** (N=150)**

Number (%) of patients with at least one adverse reaction

297 (99)

149 (99)

259 (86)

127 (85)

Blood and lymphatic system disorders

Neutropenia b

154 (51)

31 (21)

145 (48)

24 (16)

Thrombocytopenia

89 (30) a

44 (29) a

66 (22) a

39 (26) a

Leukopenia

38 (13)

8 (5)

27 (9)

5 (3)

Febrile neutropenia b

28 (9)

0 (0.0)

28 (9)

0 (0.0)

General disorders and administration site conditions

Fatigue and asthenia

140 (47)

64 (43)

26 (9) a

18 (12) a

Pyrexia b

80 (27)

35 (23)

9 (3) a

7 (5) a

Edema peripheral

52 (17)

17 (11)

4 (1) a

3 (2) a

Pain

11 (4) a

3 (2) a

5 (2)

1 (<1)

Infections and infestations

Upper respiratory tract infection b

93 (31)

19 (13)

9 (3)

1 (<1)

Pneumonia b

58 (19)

20 (13)

47 (16)

15 (10)

Neutropenic sepsis b

3 (1) a

0 (0.0) a

3 (1)

0 (0.0)

Gastrointestinal disorders

Diarrhea

66 (22)

28 (19)

3 (1) a

2 (1) a

Constipation

65 (22)

22 (15)

7 (2)

0 (0.0)

Nausea

45 (15)

17 (11)

3 (1) a

2 (1) a

Vomiting

23 (8)

6 (4)

3 (1)

0 (0.0)

Musculoskeletal and connective tissue disorders

Back pain b

59 (20)

24 (16)

15 (5)

6 (4)

Bone pain b

54 (18)

21 (14)

22 (7)

7 (5)

Muscle spasms

46 (15)

11 (7)

1 (<1) a

1 (<1) a

Arthralgia

26 (9)

7 (5)

2 (<1) a

1 (<1) a

Pain in extremity

20 (7) a

9 (6) a

6 (2)

0 (0.0)

Respiratory, thoracic and mediastinal disorders

Dyspnea b

76 (25)

25 (17)

17 (6)

7 (5)

Cough

60 (20)

15 (10)

2 (<1) a

1 (<1) a

Chronic obstructive pulmonary disease b

5 (2) a

0 (0.0) a

4 (1)

0 (0.0)

Nervous system disorders

Peripheral neuropathy

52 (17)

18 (12)

5 (2) a

2 (1) a

Dizziness

37 (12)

14 (9)

4 (1) a

2 (1) a

Headache

23 (8)

8 (5)

1 (<1) a

0 (0.0) a

Tremor

17 (6)

2 (1)

2 (<1) a

0 (0.0) a

Depressed level of consciousness

5 (2) a

0 (0.0) a

3 (1)

0 (0.0)

Metabolism and nutrition disorders

Decreased appetite

38 (13)

12 (8)

3 (1) a

2 (1) a

Hypokalemia

28 (9) a

12 (8) a

12 (4)

4 (3)

Hypocalcemia

12 (4) a

9 (6) a

5 (2)

1 (<1)

Skin and subcutaneous tissue disorders

Rash

23 (8)

2 (1)

3 (1)

0 (0.0)

Pruritus

22 (7)

5 (3)

0 (0.0) a

0 (0.0) a

Hyperhidrosis

15 (5)

1 (<1)

0 (0.0) a

0 (0.0) a

Investigations

Neutrophil count decreased

15 (5)

1 (<1)

14 (5)

1 (<1)

Platelet count decreased

10 (3) a

3 (2) a

8 (3)

2 (1)

White blood cell count decreased

8 (3) a

1 (<1) a

8 (3)

0 (0.0)

Alanine aminotransferase increased

7 (2) a

2 (1) a

5 (2)

0 (0.0)

Aspartate aminotransferase increased

4 (1) a

2 (1) a

3 (1)

0 (0.0)

Lymphocyte count decreased

3 (1) a

1 (<1) a

3 (1)

0 (0.0)

Renal and urinary disorders

Renal failure

31 (10) a

18 (12) a

19 (6)

8 (5)

Injury, poisoning and procedural complications

Femur fracture b

5 (2) a

1 (<1) a

5 (2)

1 (<1)

Reproductive system and breast disorders

Pelvic pain

6 (2) a

3 (2) a

4 (1)

0 (0.0)

Adverse Reaction

Grades 1-4
N=28
%

Grade 3 or 4
N=28
%

Rash, maculo-papular

71

3.6

Constipation

71

0

Fatigue

68

0

Nausea

36

0

Diarrhea

32

3.6

Cough

29

0

Dyspnea

29

0

Peripheral Edema

29

3.6

Upper respiratory tract infection

29

0

Muscle spasms

25

0

Hypothyroidism

21

0

Dry skin

21

0

Chills

21

0

• Denominator is the number of patients for whom there is a baseline and at least one post baseline assessment for the laboratory parameter.

Laboratory Abnormality

Grades 1-4*
%

Grades 3-4*
%

Hematology

Decreased Absolute Neutrophil Count

96

50

Decreased White Blood Cells

79

3.6

Decreased Hemoglobin

54

0

Decreased Platelets

54

0

Chemistry

Elevated Creatinine

86

3.6

Elevated Glucose

57

7

Decreased Albumin

54

0

Decreased Phosphate

54

25

Decreased Calcium

50

0

Increased Alanine Aminotransferase (ALT)

32

0

Increased Aspartate Aminotransferase (AST)

25

0

Elevated Creatine Kinase

25

7

Decreased Magnesium

14

0

Elevated Alkaline Phosphate

14

3.6

Data cutoff: 01 April 2011

Patient Characteristics

Median age, years (range)

61 (37-88)

64 (34-88)

Age distribution, n (%)

<65 years

65 (60.2)

60 (53.1)

≥65 years

43 (39.8)

53 (46.9)

Sex, n (%)

Male

57 (52.8)

62 (54.9)

Female

51 (47.2)

51 (45.1)

Race/ethnicity, n (%)

White

86 (79.6)

92 (81.4)

Black or African American

16 (14.8)

17 (15)

All other race

6 (5.6)

4 (3.6)

ECOG Performance, n (%)

Status 0-1

95 (87.9)

100 (88.5)

Disease Characteristics

Number of prior therapies

Median (min, max)

5 (2, 12)

5 (2, 13)

Prior transplant, n (%)

82 (75.9)

84 (74.3)

Refractory to bortezomib and lenalidomide, n (%)

64 (59.3)

69 (61.1)

a Results are prior to the addition of dexamethasone.
b ORR = PR + CR per EBMT criteria.
CI, confidence interval; NE, not established (the median has not yet been reached).
Data cutoff: 01 April 2011

POMALYST****a
(n=108)

POMALYST + Low-dose Dex
(n=113)

Response

Overall Response Rate (ORR),b n (%)

8 (7.4)

33 (29.2)

95% CI for ORR (%)

(3.3, 14.1)

(21.0, 38.5)

Complete Response (CR), n (%)

0 (0.0)

1 (0.9)

Partial Response (PR), n (%)

8 (7.4)

32 (28.3)

Duration of Response (DOR)

Median, months

NE

7.4

95% CI for DOR (months)

NE

(5.1, 9.2)

Data cutoff: 01March 2013

POMALYST + Low-dose Dex

High-dose Dex

(N=302)

(N=153)

Patient Characteristics

Median Age, years (range)

64 (35, 84)

65 (35, 87)

Age Distribution n (%)

< 65 years

158 (52)

74 (48)

≥ 65 years

144 (48)

79 (52)

Sex n (%)

Male

181 (60)

87 (57)

Female

121 (40)

66 (43)

Race/Ethnicity n (%)

White

244 (81)

113 (74)

Black or African American

4 (1)

3 (2)

Asian

4 (1)

0 (0)

Other Race

2 (1)

2 (1)

Not Collected

48 (16)

35 (23)

ECOG Performance n (%)

Status 0

110 (36)

36 (24)

Status 1

138 (46)

86 (56)

Status 2

52 (17)

25 (16)

Status 3

0 (0)

3 (2)

Missing

2 (1)

3 (2)

Disease Characteristics

Number of Prior Therapies

Median, (Min, Max)

5 (2, 14)

5 (2, 17)

Prior stem cell transplant n (%)

214 (71)

105 (69)

Refractory to bortezomib and lenalidomide n (%)

225 (75)

113 (74)

Note: CI=Confidence interval; HD-Dex=High dose dexamethasone; IRAC=Independent Review Adjudication Committee; LD-Dex=Low dose dexamethasone.
a The median is based on Kaplan-Meier estimate.
b Based on Cox proportional hazards model comparing the hazard functions associated with treatment groups, stratified by age (≤75 vs >75), diseases population (refractory to both Lenalidomide and Bortezomib vs not refractory to both drugs), and prior number of antimyeloma therapy (=2 vs >2), stratification factors for the trial.
c The p-value is based on a stratified log-rank test with the same stratification factors as the above Cox model.
d 53% of patients in the High-dose Dex arm subsequently received POMALYST.
e Based on Cox proportional hazards model (unstratified) comparing the hazard functions associated with treatment groups.
f The p-value is based on an unstratified log-rank test.
g Alpha control for PFS and OS.
Data cutoff: 07 Sep 2012 for PFS
Data cutoff: 01 Mar 2013 for OS and ORR

POMALYST + Low-dose Dex

High-dose Dex

(N=302)

(N=153)

Progression Free Survival Time

Number (%) of events

164 (54.3)

103 (67.3)

Mediana (2-sided 95% CI) (months)

3.6 [3.0, 4.6]

1.8 [1.6, 2.1]

Hazard Ratio (Pom+LD-Dex:HD-Dex) 2-Sided 95% CIb

0.45 [0.35, 0.59]

Log-Rank Test 2-sided P-Valuec

<0.001

Overall Survival Timed

Number (%) of deaths

147 (48.7)

86 (56.2)

Mediana (2-sided 95% CI) (months)

12.4 [10.4, 15.3]

8.0 [6.9, 9.0]

Hazard Ratio (Pom+LD-Dex:HD-Dex) 2-Sided 95% CIe

0.70 [0.54, 0.92]

Log-Rank Test 2-sided P-Value f, g

0.009

Overall Response Rate, n (%)

71 (23.5)

6 (3.9)

Complete Response

1 (0.3)

0

Very Good Partial Response

8 (2.6)

1 (0.7)

Partial Response

62 (20.5)

5 (3.3)

CI: confidence interval, ORR: overall response rate, CR: complete response, PR: partial response
1 CR includes one HIV-negative patient who achieved a cCR.
2 Calculated as date of first documented response to date of first documented disease progression, receipt of new treatment or second course of treatment, or death due to any cause, whichever occurs first. Median estimate is from Kaplan-Meier analysis.
3 From Kaplan-Meier analysis.

All Patients
N=28

HIV-Positive
N=18

HIV-Negative
N=10

ORR 1, n (%)

20 (71)

12 (67)

8 (80)

[95% CI]

[51, 87]

(41, 87)

(44, 98)

CR 1, n (%)

4 (14)

3 (17)

1 (10)

PR, n (%)

16 (57)

9 (50)

7 (70)

Duration of Response, KS 2,

12.1

12.5

10.5

Median in months [95% CI]3

[7.6, 16.8]

[6.5, 24.9]

[3.9, 24.2]

Duration of Response, KS (%)

Percent greater than 12 months

50

58

38

Percent greater than 24 months

20

17

25

1 mg bottles of 21

(NDC 59572-501-21)

1 mg bottles of 100

(NDC 59572-501-00)

2 mg bottles of 21

(NDC 59572-502-21)

2 mg bottles of 100

(NDC 59572-502-00)

3 mg bottles of 21

(NDC 59572-503-21)

3 mg bottles of 100

(NDC 59572-503-00)

4 mg bottles of 21

(NDC 59572-504-21)

4 mg bottles of 100

(NDC 59572-504-00)

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: March 2023

MEDICATION GUIDE
POMALYST® (POM-uh-list)
(pomalidomide)
capsules

What is the most important information I should know about POMALYST?

Before you begin taking POMALYST, you must read and agree to all of the instructions in the POMALYST REMS® program. For more information, call 1-888-423-5436 or go to www.pomalystrems.com. Before prescribing POMALYST, your healthcare provider will explain the POMALYST REMS program to you and have you sign the Patient-Physician Agreement Form.

POMALYST can cause serious side effects including:

•

**Possible birth defects (deformed babies) or death of an unborn baby.** Females who are pregnant or who plan to become pregnant must not take POMALYST.  

POMALYST is similar to the medicine thalidomide (THALOMID). We know thalidomide can cause severe life-threatening birth defects. POMALYST has not been tested in pregnant females. POMALYST has harmed unborn animals in animal testing.

**Females must not get pregnant:**

o

For at least 4 weeks before starting POMALYST

o

While taking POMALYST

o

During any breaks (interruptions) in your treatment with POMALYST

o

For at least 4 weeks after stopping POMALYST
**Females who can become pregnant:**

o

Will have pregnancy tests weekly for 4 weeks, then every 4 weeks if your menstrual cycle is regular, or every 2 weeks if your menstrual cycle is irregular.  

If you miss your period or have unusual bleeding, you will need to have a pregnancy test and receive counseling.

o

Must agree to use two acceptable forms of birth control at the same time, for at least 4 weeks before, while taking, during any breaks (interruptions) in your treatment, and for at least 4 weeks after stopping POMALYST.

o

Talk with your healthcare provider to find out about options for acceptable forms of birth control that you may use to prevent pregnancy before, during, and after treatment with POMALYST.
**If you become pregnant while taking POMALYST, stop taking it right away and call your healthcare provider.** If your healthcare provider is not available, you can call the REMS Call Center at 1-888-423-5436.  

Healthcare providers and patients should report all cases of pregnancy to:

o

FDA MedWatch at 1-800-FDA-1088, and

o

REMS Call Center at 1-888-423-5436
There is a pregnancy exposure registry that monitors the outcomes of females who take POMALYST during pregnancy, or if their male partner takes POMALYST and they are exposed during pregnancy. You can enroll in this registry by calling the REMS Call Center at the phone number listed above.


**POMALYST can pass into human semen:**

o

Males, including those who have had a vasectomy, must always use a latex or synthetic condom during any sexual contact with a pregnant female or a female that can become pregnant while taking POMALYST, during any breaks (interruptions) in your treatment with POMALYST, and for 4 weeks after stopping POMALYST.

o

Do not have unprotected sexual contact with a female who is or could become pregnant. Tell your healthcare provider if you do have unprotected sexual contact with a female who is or could become pregnant.

o

Do not donate sperm while taking POMALYST, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping POMALYST. If a female becomes pregnant with your sperm, the baby may be exposed to POMALYST and may be born with birth defects.
**Men, if your female partner becomes pregnant, you should call your healthcare provider right away.**

•

**Blood clots in your arteries, veins, and lungs, heart attack, and stroke can happen if you take POMALYST.** Most people who take POMALYST will also take a blood thinner medicine to help prevent blood clots.  

Before taking POMALYST, tell your healthcare provider:

o

If you have had a blood clot in the past

o

If you have high blood pressure, smoke, or if you have been told you have a high level of fat in your blood (hyperlipidemia)

o

About all the medicines you take. Certain other medicines can also increase your risk for blood clots  

Call your healthcare provider or get medical help right away if you get any of the following during treatment with POMALYST:

•

**Signs or symptoms of a blood clot in the lung, arm, or leg may include**: shortness of breath, chest pain, or arm or leg swelling

•

**Signs or symptoms of a heart attack may include**: chest pain that may spread to the arms, neck, jaw, back, or stomach area (abdomen), feeling sweaty, shortness of breath, feeling sick or vomiting

•

**Signs or symptoms of stroke may include:** sudden numbness or weakness, especially on one side of the body, severe headache or confusion, or problems with vision, speech, or balance.

What is POMALYST?

POMALYST is a prescription medicine used to treat adults with:

•

**Multiple myeloma.** POMALYST is taken along with the medicine dexamethasone, in people who:

o

have received at least 2 prior medicines to treat multiple myeloma, including a type of medicine known as a proteasome inhibitor and lenalidomide, and

o

their disease has become worse during treatment or within 60 days of finishing the last treatment

•

**AIDS-related Kaposi sarcoma (KS).** POMALYST is taken when highly active antiretroviral therapy (HAART) has not worked well enough or stopped working (failed)

•

**KS who do not have HIV infection (HIV negative).**

It is not known if POMALYST is safe and effective in children.

Who should not take POMALYST?

Do not take POMALYST if you:

•

are pregnant, plan to become pregnant, or become pregnant during treatment with POMALYST.**See "What is the most important information I should know about POMALYST?"**

•

are allergic to pomalidomide or any of the ingredients in POMALYST.**See the end of this Medication Guide for a complete list of ingredients in POMALYST.**

What should I tell my healthcare provider before taking POMALYST?

Before you take POMALYST, tell your healthcare provider if you:

•

smoke cigarettes. POMALYST may not work as well in people who smoke

•

have liver problems

•

have kidney problems and are receiving hemodialysis treatment

•

have any other medical conditions

•

are breastfeeding.**You should not** breastfeed during treatment with POMALYST. It is not known if POMALYST passes into your breast milk and can harm your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. POMALYST and other medicines may affect each other, causing serious side effects. Talk with your healthcare provider before taking any new medicines.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist.

How should I take POMALYST?

•

Take POMALYST exactly as prescribed and follow all the instructions of the POMALYST REMS program.

•

Swallow POMALYST capsules whole with water 1 time a day.**Do not break, chew, or open your capsules**.

•

**POMALYST may be taken with or without food.**

•

Take POMALYST at about the same time each day.

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If you are on hemodialysis, take POMALYST after hemodialysis, on hemodialysis days.

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Do not open the POMALYST capsules or handle them any more than needed. If you touch a broken POMALYST capsule or the medicine in the capsule, wash the area of your body right away with soap and water.

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If you miss a dose of POMALYST and it has been less than 12 hours since your regular time, take it as soon as you remember. If it has been more than 12 hours, just skip your missed dose. Do not take 2 doses at the same time.

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If you take too much POMALYST, call your healthcare provider right away.

What should I avoid while taking POMALYST?

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See "What is the most important information I should know about POMALYST?"

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**Females: Do not get pregnant and do not breastfeed while taking POMALYST**.

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**Males: Do not donate sperm.**

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**Do not share POMALYST with other people.** It may cause birth defects and other serious problems.

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**Do not donate blood** while you take POMALYST, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping POMALYST. If someone who is pregnant gets your donated blood, her baby may be exposed to POMALYST and may be born with birth defects.

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POMALYST can cause dizziness and confusion. Avoid taking other medicines that may cause dizziness and confusion during treatment with POMALYST. Avoid situations that require you to be alert until you know how POMALYST affects you.

What are the possible side effects of POMALYST?

POMALYST can cause serious side effects, including:

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**See "What is the most important information I should know about POMALYST?"**

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**Low white blood cells (neutropenia), low platelets (thrombocytopenia), and low red blood cells (anemia) are common with POMALYST, but can also be serious.** You may need a blood transfusion or certain medicines if your blood counts drop too low. Your blood counts should be checked weekly for the first 8 weeks of treatment and monthly after that.

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**Severe liver problems, including liver failure and death.** Your healthcare provider should do blood tests to check your liver function during your treatment with POMALYST. Tell your healthcare provider right away if you develop any of the following symptoms of liver problems:

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Yellowing of your skin or the white part of your eyes (jaundice)

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Dark or brown (tea-colored) urine

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Pain on the upper right side of your stomach area (abdomen)

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Bleeding or bruising more easily than normal

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Feeling very tired

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**Severe allergic reactions and severe skin reactions** can happen with POMALYST and may cause death.  

Call your healthcare provider if you develop any of the following signs or symptoms during treatment with POMALYST:

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a red, itchy, skin rash

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peeling of your skin or blisters

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severe itching

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fever

Get emergency medical help right away if you develop any of the following signs or symptoms during treatment with POMALYST:

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swelling of your lips, mouth, tongue, or throat

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trouble breathing or swallowing

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raised red areas on your skin (hives)

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a very fast heartbeat

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you feel dizzy or faint

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**Dizziness and confusion. See "What should I avoid while taking POMALYST?**

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**Nerve damage**. Stop taking POMALYST and call your healthcare provider if you develop symptoms of nerve damage including: numbness, tingling, pain, burning sensation in your hands, legs, or feet.

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**Risk of new cancers (malignancies).** New cancers, including certain blood cancers (acute myelogenous leukemia or AML) have been seen in people who received POMALYST. Talk with your healthcare provider about your risk of developing new cancers if you take POMALYST.

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**Tumor lysis syndrome (TLS).** TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure, and sometimes death. Your healthcare provider may do blood tests to check you for TLS.

Your healthcare provider may tell you to stop taking POMALYST if you develop certain serious side effects during treatment.

The most common side effects of POMALYST in people with Multiple Myeloma include:

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tiredness and weakness

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constipation

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nausea

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diarrhea

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shortness of breath

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upper respiratory tract infection

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back pain

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fever

The most common side effects of POMALYST in people with KS include:

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tiredness

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diarrhea

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abnormal kidney function tests

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decreased phosphate and calcium in the blood

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rash. See**"Severe allergic reactions and severe skin reactions"** above.

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nausea

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constipation

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increased blood sugar

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decreased albumin in the blood

These are not all the possible side effects of POMALYST.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store POMALYST?

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Store POMALYST at room temperature between 68°F to 77°F (20°C to 25°C).

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Return any unused POMALYST to POMALYST REMS by calling 1-888-423-5346 or your healthcare provider.

Keep POMALYST and all medicines out of the reach of children.

General information about the safe and effective use of POMALYST.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take POMALYST for conditions for which it was not prescribed. Do not give POMALYST to other people, even if they have the same symptoms you have. It may harm them and may cause birth defects.

If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about POMALYST that is written for health professionals.

For more information, call 1-888-423-5436 or go to www.pomalystrems.com.

What are the ingredients in POMALYST?

Active ingredient: pomalidomide

Inactive ingredients: mannitol, pregelatinized starch, and sodium stearyl fumarate.

The 1-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, yellow iron oxide, white ink, and black ink.
The 2-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, yellow iron oxide, FD&C red 3, and white ink.
The 3-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, yellow iron oxide, and white ink.
The 4-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 1, FD&C blue 2, and white ink.

Marketed by: Bristol-Myers Squibb Company, Princeton, NJ 08543 USA
POMALYST® and POMALYST REMS® are trademarks of Celgene Corporation, a Bristol- Myers Squibb company.
POMMG.014 3/2023