Boxed Warning | 05/2022 |
Indications and Usage, COVID-19 ( |
05/2022 |
Indications and Usage, Alopecia Areata ( |
06/2022 |
Dosage and Administration ( |
05/2022 |
Dosage and Administration ( |
06/2022 |
Warnings and Precautions ( |
12/2021 |
Warnings and Precautions ( |
05/2022 |
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≥500 cells/μL | Maintain dosage |
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Interrupt OLUMIANT until ALC ≥500 cells/μL | |
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≥1000 cells/μL | Maintain dosage |
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Interrupt OLUMIANT until ANC ≥1000 cells/μL | |
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≥8 g/dL | Maintain dosage |
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Interrupt OLUMIANT until hemoglobin ≥8 g/dL |
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Absolute Lymphocyte Count (ALC) | ≥200 cells/μL | Maintain dosage |
<200 cells/μL | Interrupt OLUMIANT until ALC ≥200 cells/μL | |
Absolute Neutrophil Count (ANC) | ≥500 cells/μL | Maintain dosage |
<500 cells/μL | Interrupt OLUMIANT until ANC ≥500 cells/μL |
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Mild | 60 – <90 mL/minute/1.73 m2 | 2 mg once daily |
Moderate | 30 - <60 mL/min/1.73 m2 | 1 mg once daily |
Severe | <30 mL/minute/1.73 m2 | Not recommended |
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Mild | 60 - <90 mL/min/1.73m2 | 4 mg once daily |
Moderate | 30 - <60 mL/min/1.73m2 | 2 mg once daily |
Severe | 15 - <30 mL/min/1.73m2 | 1 mg once daily |
End Stage Renal Disease, Patients on Dialysis, or Acute Kidney Injury | <15 mL/min/1.73m2 | Not recommended |
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If the recommended dosage is 2 mg once daily |
If the recommended dosage is 4 mg once daily |
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Mild | 60 – <90 mL/minute/1.73 m2 | Maintain dosage | |
Moderate | 30 – <60 mL/min/1.73 m2 | Reduce to 1 mg once daily | Reduce to 2 mg once daily |
Severe | <30 mL/minute/1.73 m2 | Not recommended |
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Strong OAT3 inhibitors (e.g., probenecid) |
If the recommended dosage is 4 mg once daily, reduce dosage to 2 mg once daily. |
If the recommended dosage is 2 mg once daily, reduce dosage to 1 mg once daily. | |
If the recommended dosage is 1 mg once daily, consider discontinuing probenecid. |
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10 mL | 10 mL |
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15 mL | 15 mL |
or OG tube |
30 mL | 15 mL |
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Upper respiratory tract infectionsa | 11.7 | 16.3 | 14.7 |
Nausea | 1.6 | 2.7 | 2.8 |
Herpes simplexb | 0.7 | 0.8 | 1.8 |
Herpes zoster | 0.4 | 1.0 | 1.4 |
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N = 1310 |
N = 1307 |
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ALT ≥3 x ULNa | 201(16.0) | 230 (18.1) |
AST ≥3 x ULNa | 117 (9.4) | 149 (11.8) |
Thrombocytosis >600,000 cells/mm3a | 34 (4.6) | 59 (7.9) |
Creatine phosphokinase (CPK) >5 x ULNa, b | 38 (4.7) | 36 (4.5) |
Neutropenia <1000 cells/mm3a | 22 (1.8) | 26 (2.2) |
Deep vein thrombosis | 18 (1.4) | 20 (1.5) |
Pulmonary embolism | 11 (0.8) | 20 (1.5) |
Urinary tract infection | 13 (1.0) | 19 (1.5) |
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Upper respiratory tract infectionsb
(URTI) |
19.9 | 18.4 | 21.3 |
Headache | 5.4 | 5.5 | 6.6 |
Acnec | 2.2 | 5.8 | 5.9 |
Hyperlipidemiad | 3.0 | 3.6 | 5.9 |
Blood creatine phosphokinase increased | 1.3 | 0.8 | 4.3 |
Urinary tract infections (UTI)e | 2.2 | 3.8 | 3.7 |
Liver enzyme elevationsf | 2.4 | 1.1 | 3.0 |
Folliculitisg | 0.8 | 1.4 | 2.2 |
Fatigue | 1.1 | 0.8 | 2.2 |
Lower respiratory tract infections (LRTI)h | 0.8 | 2.2 | 2.0 |
Nausea | 1.6 | 2.7 | 2.0 |
Genital Candida infectionsi | 0.3 | 2.2 | 1.3 |
Anemia | 0.3 | 0.3 | 1.3 |
Neutropeniaj | 0.8 | 0.3 | 1.3 |
Abdominal paink | 2.2 | 3.8 | 0.9 |
Herpes zoster | 0.5 | 1.4 | 0.9 |
Weight increased | 0.3 | 1.6 | 0.9 |
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RA-1 (N=301) | 41 | 57 | 54 | 75 | 78 |
RA-2 (N=145) | 31 | 67 | 83 | 67 | 88 |
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2 mg/day + cDMARDs ∆ (95% CI) |
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2 mg/day + cDMARDs ∆ (95% CI) |
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Week 12 % |
39 | 66 27 (18, 35) |
27 | 49 22 (12, 32) |
Week 24 % |
42 | 61 19 (10, 28) |
27 | 45 18 (8, 27) |
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Week 12 % |
13 | 34 21 (13, 28) |
8 | 20 12 (5, 19) |
Week 24 % |
21 | 41 20 (12, 28) |
13 | 23 10 (2, 18) |
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Week 12 % |
3 | 18 15 (9, 20) |
2 | 13 11 (5, 16) |
Week 24 % |
8 | 25 17 (11, 24) |
3 | 13 10 (4, 16) |
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Week 12 % |
9 | 26 (10, 24) |
4 | 11 (2, 12) |
Week 24 % |
11 | 31 (13, 27) |
6 | 11 (-1, 11) |
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+ cDMARDs |
2 mg/day + cDMARDs |
+ cDMARDs |
2 mg/day + cDMARDs |
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Baseline | 24 (15) | 24 (14) | 28 (16) | 31 (16) |
Week 12 | 15 (14) | 11 (13) | 20 (16) | 19 (18) |
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Baseline | 13 (7) | 14 (9) | 17 (11) | 19 (12) |
Week 12 | 8 (8) | 5 (6) | 12 (10) | 10 (12) |
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Baseline | 57 (23) | 60 (21) | 65 (19) | 62 (22) |
Week 12 | 43 (24) | 34 (25) | 55 (25) | 46 (28) |
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Baseline | 60 (21) | 62 (20) | 66 (19) | 67 (19) |
Week 12 | 44 (23) | 36 (25) | 56 (25) | 46 (26) |
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Baseline | 62 (17) | 64 (17) | 67 (19) | 67 (17) |
Week 12 | 41 (24) | 33 (22) | 50 (26) | 36 (24) |
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Baseline | 1.50 (0.60) | 1.51 (0.62) | 1.78 (0.57) | 1.71 (0.55) |
Week 12 | 1.17 (0.62) | 0.96 (0.69) | 1.59 (0.68) | 1.31 (0.72) |
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Baseline | 17.7 (20.4) | 18.2 (21.5) | 20.6 (25.3) | 19.9 (22.5) |
Week 12 | 17.2 (19.3) | 8.6 (14.6) | 19.9 (23.0) | 13.5 (20.1) |
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2 mg/day |
4 mg/day |
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2 mg/day |
4 mg/day |
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SALT ≤ 20 Difference from Placebo (95% CI) |
5% | 22% 16% (10, 23) |
35% 30% (23, 36) |
3% | 17% 15% (8, 22) |
32% 30% (23, 36) |
SALT ≤ 10 Difference from Placebo (95% CI) |
4% | 13% 9% (3, 15) |
26% 22% (16, 28) |
1% | 11% 10% (5, 16)a |
24% 23% (17, 29) |
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Scalp Hair Assessment PRO score of 0 or 1b
Difference from Placebo (95% CI) |
5% | 16% 11% (5, 18) |
33% 28% (21, 34) |
4% | 16% 12% (5, 19) |
34% 30% (23, 37) |
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50 % to 94% Scalp Hair Loss N SALT ≤20 |
166 8% |
147 33% |
248 48% |
95 % to 100% Scalp Hair Loss N SALT ≤20 |
178 1% |
193 10% |
267 21% |
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1 mg | 2 mg | 4 mg |
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Very Light Pink | Light Pink | Medium Pink |
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Round | Oblong | Round |
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Lilly | Lilly | Lilly |
1 | 2 | 4 | |
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0002-4732-30 | 0002-4182-30 | 0002-4479-30 |
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OLUMIANT is a medicine that affects your immune system. OLUMIANT can lower the ability of your immune system to fight infections. Some people have had serious infections while taking OLUMIANT, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections.
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You should not start taking OLUMIANT if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles. Before starting OLUMIANT, tell your healthcare provider if you:
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After starting OLUMIANT, call your healthcare provider right away if you have any symptoms of an infection. OLUMIANT can make you more likely to get infections or, make worse any infection that you have. If you get a serious infection, your healthcare provider may stop your treatment with OLUMIANT until your infection is controlled. OLUMIANT may increase your risk of certain cancers by changing the way your immune system works.
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Get emergency help right away if you have any symptoms of a heart attack or stroke while taking OLUMIANT, including:
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Blood clots in the veins of your legs (deep vein thrombosis, DVT) or lungs (pulmonary embolism, PE) and arteries (arterial thrombosis) can happen in some people taking OLUMIANT. This may be life-threatening and cause death. Blood clots in the veins of the legs (deep vein thrombosis, DVT) and lungs (pulmonary embolism, PE) have happened more often in people who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking a medicine in the class of medicines called Janus kinase (JAK) inhibitors.
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Symptoms such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat, that may mean you are having an allergic reaction have been seen in people taking OLUMIANT. Some of these reactions were serious. If any of these symptoms occur during treatment with OLUMIANT, stop taking OLUMIANT and get emergency help right away. |
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Your healthcare provider should do blood tests before you start taking OLUMIANT and while you take OLUMIANT to check for the following:
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You should not take OLUMIANT if your lymphocyte count, neutrophil count, or red blood cell count is too low or your liver tests are too high. Your healthcare provider may stop your OLUMIANT treatment for a period of time if needed because of changes in these blood test results. See " |
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OLUMIANT is a prescription medicine that is a Janus Kinase (JAK) inhibitor. OLUMIANT is used to treat:
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It is not known if OLUMIANT is safe and effective in children. | |||
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OLUMIANT and other medicines may affect each other causing side effects.
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Ask your healthcare provider or pharmacist if you are not sure if you are taking one of these medicines. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. |
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See “ |
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Store OLUMIANT at room temperature between 68°F to 77°F (20°C to 25°C). |
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Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use OLUMIANT for a condition for which it was not prescribed. Do not give OLUMIANT to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about OLUMIANT that is written for health professionals. |
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OLUMIANT is a registered trademark of Eli Lilly and Company. Copyright © 2018, 2022, Eli Lilly and Company. All rights reserved. For more information, call 1-800-545-5979 or go to the following website: www.olumiant.com. |