Livalo (Pitavastatin Calcium) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

The following serious adverse reactions are discussed in greater detail in other sections of the label:

• Rhabdomyolysis with myoglobinuria and acute renal failure and myopathy (including myositis) [see Warnings and Precautions ].
• Liver Enzyme Abnormalities [see Warning and Precautions].

Of 4,798 patients enrolled in 10 controlled clinical studies and 4 subsequent open-label extension studies, 3,291 patients were administered pitavastatin 1 mg to 4 mg daily. The mean continuous exposure of pitavastatin (1 mg to 4 mg) was 36.7 weeks (median 51.1 weeks). The mean age of the patients was 60.9 years (range; 18 years — 89 years) and the gender distribution was 48% males and 52% females. Approximately 93% of the patients were Caucasian, 7% were Asian/Indian, 0.2% were African American and 0.3% were Hispanic and other.

Clinical Studies Experience

Because clinical studies on LIVALO are conducted in varying study populations and study designs, the frequency of adverse reactions observed in the clinical studies of LIVALO cannot be directly compared with that in the clinical studies of other HMG-CoA reductase inhibitors and may not reflect the frequency of adverse reactions observed in clinical practice.

Adverse reactions reported in ≥ 2% of patients in controlled clinical studies and at a rate greater than or equal to placebo are shown in Table 1. These studies had treatment duration of up to 12 weeks.

Table 1. Adverse Reactions* Reported by ≥2.0% of Patients Treated with LIVALO and > Placebo in Short-Term Controlled Studies

* Adverse reactions by MedDRA preferred term.
Adverse Reactions*	Placebo N= 208	LIVALO 1 mg N=309	LIVALO 2 mg N=951	LIVALO 4 mg N=1540
Back Pain	2.9%	3.9%	1.8%	1.4%
Constipation	1.9%	3.6%	1.5%	2.2%
Diarrhea	1.9%	2.6%	1.5%	1.9%
Myalgia	1.4%	1.9%	2.8%	3.1%
Pain in extremity	1.9%	2.3%	0.6%	0.9%

Other adverse reactions reported from clinical studies were arthralgia, headache, influenza, and nasopharyngitis.

The following laboratory abnormalities have also been reported: elevated creatine phosphokinase, transaminases, alkaline phosphatase, bilirubin, and glucose.

In controlled clinical studies and their open-label extensions, 3.9% (1 mg), 3.3% (2 mg), and 3.7% (4 mg) of pitavastatin-treated patients were discontinued due to adverse reactions. The most common adverse reactions that led to treatment discontinuation were: elevated creatine phosphokinase (0.6% on 4 mg) and myalgia (0.5% on 4 mg).

Hypersensitivity reactions including rash, pruritus, and urticaria have been reported with LIVALO.

REPORTS OF SUSPECTED LIVALO SIDE EFFECTS / ADVERSE REACTIONS

Possible Livalo side effects / adverse reactions in 81 year old male

Reported by a individual with unspecified qualification from Japan on 2011-10-04

Patient: 81 year old male

Reactions: Bladder Cancer

Adverse event resulted in: life threatening event

Suspect drug(s):
Livalo
    Dosage: 1 mg (1 mg, 1 in 1 d), per oral
    Administration route: Oral
    Indication: Hyperlipidaemia
    Start date: 2006-06-24

Magmitt (Magnesium Oxide)
    Dosage: 1500 mg (500 mg, 3 in 1 d), per oral
    Administration route: Oral
    Indication: Constipation
    Start date: 2006-06-24

Micardis
    Dosage: 40 mg (40 mg, 1 in 1 d), per oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2006-06-24

Actos
    Dosage: 15 mg (15 mg, 1 in 1 d), per oral;
    Indication: Blood Glucose Abnormal
    Start date: 2006-06-24
    End date: 2008-05-16

Actos
    Dosage: 15 mg (15 mg, 1 in 1 d), per oral;
    Indication: Blood Glucose Abnormal
    Start date: 2008-10-10
    End date: 2010-08-21

Possible Livalo side effects / adverse reactions in 79 year old male

Reported by a physician from Japan on 2011-10-11

Patient: 79 year old male

Reactions: Hepatic Function Abnormal, Malaise

Adverse event resulted in: hospitalization

Suspect drug(s):
Livalo

Other drugs received by patient: Claritin /00917501/; Singulair

Possible Livalo side effects / adverse reactions in 79 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-13

Patient: 79 year old female weighing 61.2 kg (134.7 pounds)

Reactions: Blood Creatine Phosphokinase Increased

Suspect drug(s):
Livalo