Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The most common adverse reactions are dizziness, jaw pain, headache, musculoskeletal pain, and nausea/vomiting, and are generally associated with vasodilation.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 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 with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse reactions are shown in Table 2 and are generally related to vasodilatory effects.
Adverse Reactions Occurring in Patients with Idiopathic or Heritable PAH and with PAH Associated with Scleroderma Spectrum of Diseases (PAH/SSD) Occurring ≥10% More Frequently on FLOLAN than Conventional Therapy Adverse Reaction Idiopathic or Heritable PAH PAH/SSD FLOLAN Conventional Therapy FLOLAN Conventional Therapy (n = 52) (n = 54) (n = 56) (n = 55) Body as a whole Jaw pain 54% 0% 75% 0% Nonspecific musculoskeletal pain 35% 15% 84% 65% Headache 83% 33% 46% 5% Chills/fever/sepsis/flu-like symptoms 25% 11% 13% 11% Cardiovascular system Flushing 42% 2% 23% 0% Hypotension 27% 31% 13% 0% Tachycardia 35% 24% 43% 42% Digestive system Anorexia 25% 30% 66% 47% Nausea/Vomiting 67% 48% 41% 16% Diarrhea 37% 6% 50% 5% Skin and Appendages Skin ulcer - - 39% 24% Eczema/rash/urticaria 10% 13% 25% 4% Musculoskeletal System Myalgia 44% 31% - - Nervous system Anxiety/hyperkinesias/nervousness/tremor 21% 9% 7% 5% Hyperesthesia/hypesthesia/paresthesia 12% 2% 5% 0% Dizziness 83% 70% 59% 76% PAH = Pulmonary Arterial Hypertension, SSD = Scleroderma Spectrum of Diseases.
Adverse Events Attributable to the Drug Delivery System Chronic infusions of FLOLAN are delivered using a small, portable infusion pump through an indwelling central venous catheter.
During controlled PAH trials of up to 12 weeks’ duration, the local infection rate was about 18% and the rate for pain was about 11%.
During long‑term follow‑up, sepsis was reported at a rate of 0.3 infections/patient per year in patients treated with FLOLAN.
6.2 Postmarketing Experience The following events have been identified during postapproval use of FLOLAN.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or establish a causal relationship to drug exposure.
5 WARNINGS AND PRECAUTIONS • Pulmonary edema: Discontinue therapy if pulmonary edema occurs.
( 5.1 ) • Rebound pulmonary hypertension: Do not abruptly discontinue or decrease the dose.
( 5.2 ) • Vasodilation reactions: Monitor blood pressure and symptoms regularly during initiation and after dose change.
( 5.3 ) • Increased risk for bleeding: Increased risk for hemorrhagic complications, particularly for patients with other risk factors for bleeding.
( 5.4 ) 5.1 Pulmonary Edema If the patient develops pulmonary edema during initiation with FLOLAN, discontinue therapy and do not readminister.
Like all medications, Flolan can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: