Otezla

What Is Otezla?

Otezla (apremilast) is a phosphodiesterase 4 (PDE4) inhibitor used to treat adult patients with active psoriatic arthritis.

What Are Side Effects of Otezla?

Common side effects of Otezla include:

• diarrhea,
• headache,
• nausea,
• upper respiratory tract infection,
• vomiting,
• runny or stuffy nose,
• abdominal pain,
• fatigue,
• indigestion/heartburn,
• decreased appetite,
• insomnia,
• back pain,
• frequent bowel movements,
• depression,
• bronchitis,
• tooth abscess, and
• sinus headache.

Other side effects of Otezla include hypersensitivity, weight loss, gastroesophageal reflux disease (GERD), migraine, cough, and rash.

Dosage for Otezla

The recommended maintenance dosage is 30 mg twice daily taken orally starting on Day 6, after 5 days of an initial schedule of titration dosing.

What Drugs, Substances, or Supplements Interact with Otezla?

Otezla may interact with:

• CYP450 inducers (such as rifampin)

Tell your doctor all medications and supplements you use.

Otezla During Pregnancy and Breastfeeding

During pregnancy, Otezla should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Otezla (apremilast) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Otezla Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe diarrhea, nausea, and vomiting;
• unexplained weight loss, or if you lose a lot of weight;
• mood changes, new or worsening depression; or
• thoughts of suicide or hurting yourself.

Common side effects may include:

• nausea, diarrhea;
• headache; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Otezla (Apremilast Tablets)

 

Otezla Professional Information

SIDE EFFECTS

The following adverse reactions are described elsewhere in the labeling:

• Diarrhea, Nausea, and Vomiting [see WARNINGS AND PRECAUTIONS]
• Depression [see WARNINGS AND PRECAUTIONS]
• Weight Decrease [see WARNINGS AND PRECAUTIONS]
• Drug Interactions [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Psoriatic Arthritis Clinical Trials

OTEZLA was evaluated in 3 multicenter, randomized, double-blind, placebo-controlled trials [Studies PsA-1, PsA-2, and PsA-3] of similar design in adult patients with active psoriatic arthritis [see Clinical Studies]. Across the 3 studies, there were 1493 patients randomized equally to placebo, OTEZLA 20 mg twice daily or OTEZLA 30 mg twice daily. Titration was used over the first 5 days [see DOSAGE AND ADMINISTRATION]. Placebo patients whose tender and swollen joint counts had not improved by at least 20% were re-randomized 1:1 in a blinded fashion to either OTEZLA 20 mg twice daily or 30 mg twice daily at week 16 while OTEZLA patients remained on their initial treatment. Patients ranged in age from 18 to 83 years, with an overall median age of 51 years.

The majority of the most common adverse reactions presented in Table 2 occurred within the first 2 weeks of treatment and tended to resolve over time with continued dosing. Diarrhea, headache, and nausea were the most commonly reported adverse reactions. The most common adverse reactions leading to discontinuation for patients taking OTEZLA were nausea (1.8%), diarrhea (1.8%), and headache (1.2%). The proportion of patients with psoriatic arthritis who discontinued treatment due to any adverse reaction was 4.6% for patients taking OTEZLA 30 mg twice daily and 1.2% for placebo-treated patients.

Table 2: Adverse Reactions Reported in ≥2% of Patients on OTEZLA 30 mg Twice Daily and ≥1% Than That Observed in Patients on Placebo for up to Day 112 (Week 16)

Preferred Term	Placebo		OTEZLA 30 mg BID
	Day 1 to 5 (N=495) n (%)c	Day 6 to Day 112 (N=490) n (%)	Day 1 to 5 (N=497) n (%)	Day 6 to Day 112 (N=493) n (%)
Diarrheaa	6 (1.2)	8 (1.6)	46 (9.3)	38 (7.7)
Nauseaa	7 (1.4)	15 (3.1)	37 (7.4)	44 (8.9)
Headachea	9 (1.8)	11 (2.2)	24 (4.8)	29 (5.9)
Upper respiratory tract infectionb	3 (0.6)	9 (1.8)	3 (0.6)	19 (3.9)
Vomitinga	2 (0.4)	2 (0.4)	4 (0.8)	16 (3.2)
Nasopharyngitisb	1 (0.2)	8 (1.6)	1 (0.2)	13 (2.6)
Abdominal pain upperb	0 (0.0)	1 (0.2)	3 (0.6)	10 (2.0)
a Of the reported gastrointestinal adverse reactions, 1 subject experienced a serious adverse reaction of nausea and vomiting in OTEZLA 30 mg twice daily; 1 subject treated with OTEZLA 20 mg twice daily experienced a serious adverse reaction of diarrhea; 1 patient treated with OTEZLA 30 mg twice daily experienced a serious adverse reaction of headache. b Of the reported adverse drug reactions none were serious. c n (%) indicates number of patients and percent.

Other adverse reactions reported in patients on OTEZLA in clinical studies including extension studies:

Immune system disorders: Hypersensitivity

Investigations: Weight decrease

Gastrointestinal Disorders: Frequent bowel movement, gastroesophageal reflux disease, dyspepsia

Metabolism and Nutrition Disorders: Decreased appetite*

Nervous System Disorders: Migraine

Respiratory, Thoracic, and Mediastinal Disorders: Cough

Skin and Subcutaneous Tissue Disorders: Rash

*1 patient treated with OTEZLA 30 mg twice daily experienced a serious adverse reaction.

Psoriasis Clinical Trials

The safety of OTEZLA was assessed in 1426 subjects in 3 randomized, double-blind, placebo-controlled trials in adult subjects with moderate to severe plaque psoriasis who were candidates for phototherapy or systemic therapy. Subjects were randomized to receive OTEZLA 30 mg twice daily or placebo twice daily. Titration was used over the first 5 days [see DOSAGE AND ADMINISTRATION]. Subjects ranged in age from 18 to 83 years, with an overall median age of 46 years.

Diarrhea, nausea, and upper respiratory tract infection were the most commonly reported adverse reactions. The most common adverse reactions leading to discontinuation for subjects taking OTEZLA were nausea (1.6%), diarrhea (1.0%), and headache (0.8%). The proportion of subjects with psoriasis who discontinued treatment due to any adverse reaction was 6.1% for subjects treated with OTEZLA 30 mg twice daily and 4.1% for placebo-treated subjects.

Table 3: Adverse Reactions Reported in ≥1% of Subjects on OTEZLA and With Greater Frequency Than in Subjects on Placebo; up to Day 112 (Week 16)

Preferred Term	Placebo (N=506) n (%)	OTEZLA 30 mg BID (N=920) n (%)
Diarrhea	32 (6)	160 (17)
Nausea	35 (7)	155 (17)
Upper respiratory tract infection	31 (6)	84 (9)
Tension headache	21 (4)	75 (8)
Headache	19 (4)	55 (6)
Abdominal pain*	11 (2)	39 (4)
Vomiting	8 (2)	35 (4)
Fatigue	9 (2)	29 (3)
Dyspepsia	6 (1)	29 (3)
Decreased appetite	5 (1)	26 (3)
Insomnia	4 (1)	21 (2)
Back pain	4 (1)	20 (2)
Migraine	5 (1)	19 (2)
Frequent bowel movements	1 (0)	17 (2)
Depression	2 (0)	12 (1)
Bronchitis	2 (0)	12 (1)
Tooth abscess	0 (0)	10 (1)
Folliculitis	0 (0)	9 (1)
Sinus headache	0 (0)	9 (1)
*Two subjects treated with OTEZLA experienced serious adverse reaction of abdominal pain.

Severe worsening of psoriasis (rebound) occurred in 0.3% (4/1184) subjects following discontinuation of treatment with OTEZLA.

Behcet's Disease Clinical Trials

OTEZLA was evaluated in a Phase 3, multicenter, randomized, placebo-controlled study (BCT-002) in adult patients with Behcet's Disease (BD) with active oral ulcers. A total of 207 patients were randomized to receive OTEZLA 30 mg twice daily or placebo twice daily. Titration was used over the first 5 days [see DOSAGE AND ADMINISTRATION]. After Week 12, all patients received treatment with OTEZLA 30 mg twice daily. Patients ranged in age from 19 to 72, with a mean age of 40 years.

Diarrhea, nausea, headache, and upper respiratory tract infection were the most commonly reported adverse reactions. The proportion of patients with BD who discontinued treatment due to any adverse reaction during the placebo-controlled period of the study, was 2.9% for patients treated with OTEZLA 30 mg twice daily and 4.9% for placebo-treated patients.

Table 4: Adverse Reactions Reported in ≥5% of Patients on OTEZLA and with at least 1% Greater Frequency than Patients on Placebo; up to Week 12

Preferred Term	Placebo (N=103) n (%)	OTEZLA 30 mg twice daily (N=104) n (%)
Diarrheaa	21 (20.4)	43 (41.3)
Nauseaa	11 (10.7)	20 (19.2)
Headache	11 (10.7)	15 (14.4)
Upper respiratory tract infection	5 (4.9)	12 (11.5)
Abdominal pain upper	2(1.9)	9 (8.7)
Vomitinga	2(1.9)	9 (8.7)
Back pain	6 (5.8)	8 (7.7)
Viral upper respiratory tract infection	5 (4.9)	7 (6.7)
Arthralgia	3 (2.9)	6 (5.8)
a There were no serious adverse reactions of diarrhea, nausea or vomiting.

Read the entire FDA prescribing information for Otezla (Apremilast Tablets)