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TREPROSTINIL TILLOMED is a brand name for Treprostinil. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of idiopathic or heritable pulmonary arterial hypertension (PAH) to improve exercise tolerance and symptoms of the disease in patients classified as New York Heart Association (NYHA) functional class III.
Verbatim from this product's MHRA label. Tap a section to expand.
Treprostinil Tillomed is administered by continuous subcutaneous or intravenous infusion. Due to the risks associated with chronic indwelling central venous catheters, including serious blood stream infections, subcutaneous infusion (undiluted) is the preferred mode of administration and continuous intravenous infusion should be reserved for patients stabilised with treprostinil subcutaneous infusion and who become intolerant of the subcutaneous route, and in whom these risks are considered acceptable.
The treatment should be initiated and monitored only by clinicians experienced in the treatment of pulmonary hypertension. Adults Treatment initiation for patients new to prostacyclin therapy Treatment should be initiated under close medical supervision in a medical setting able to provide intensive care.
25 ng/kg/min. 625 ng/kg/min. 5 ng/kg/min per week. The dose should be adjusted on an individual basis and under medical supervision in order to achieve a maintenance dose at which symptoms improve and which is tolerated by the patient.
Efficacy in the main 12 week trials was only maintained if the dose was increased on average 3-4 times per month. The goal of chronic dosage adjustments is to establish a dose at which PAH symptoms are improved, whilst minimising the excessive pharmacological effects of treprostinil.
Adverse effects such as flushing, headache, hypotension, nausea, vomiting and diarrhoea are generally dependent on the dose of treprostinil administered. They may disappear as treatment continues, but should they persist or become intolerable to the patient, the infusion rate may be reduced to diminish their intensity.
During follow-up phases of clinical trials, the mean doses reached after 12 months were 26 ng/kg/min, after 24 months were 36 ng/kg/min, and after 48 months were 42 ng/kg/min. For patients with obesity (weighing ≥ 30% more than ideal body weight) initial dose and following dose increments should be based on ideal body weight.
Abrupt withdrawal or sudden marked reductions in the dose of treprostinil may cause a rebound in pulmonary arterial hypertension. It is therefore recommended that interruption of treprostinil therapy is avoided and that the infusion is re-started as soon as possible after an abrupt accidental dose reduction or interruption.
Adverse reactions observed in placebo-controlled studies and post-marketing experience with treprostinil are ranked according to frequency using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Tabulated list of adverse reactions SYSTEM ORGAN CLASS ADVERSE REACTION FREQUENCY Headache Very commonNervous system disorders Dizziness Common Cardiac disorders High output cardiac failure Not known Vasodilatation, flushing Very common Hypotension Common Bleeding event§ Common Vascular disorders Thrombophlebitis* Not known Diarrhoea, nausea Very commonGastrointestinal disorders Vomiting Common Rash Very common Pruritus Common Skin and subcutaneous tissue disorders Generalised rashes (macular or papular in nature) Not known Jaw pain Very common Myalgia, arthralgia Common Pain in extremity Common Musculoskeletal, connective tissue and bone disorders Bone pain Not known Infusion site pain, infusion site reaction, bleeding or haematoma.
Very commonGeneral disorders and administration site conditions Oedema Common Blood and lymphatic system disorders Thrombocytopenia Not known Central venous catheter- associated blood stream infection, sepsis, bacteremia ** Not known infusion site infection, subcutaneous infusion site abscess formation Not known Infections and infestations Cellulitis Not known * Cases of thrombophlebitis associated with peripheral intravenous infusion have been reported.
** Life-threatening and fatal cases have been reported. § See section "Description of selected adverse events" Description of selected adverse events Bleeding events Bleeding events were common as expected in this patient population with a high proportion of patients treated with anticoagulants.
Due to its effects on platelet aggregation, treprostinil may increase the risk of bleeding, as observed by an increased incidence of epistaxis and gastrointestinal (GI) bleeding (including gastrointestinal haemorrhage, rectal haemorrhage, gum haemorrhage, and melaena) in controlled clinical trials.
The decision to initiate therapy with treprostinil should take into consideration the high probability that a continuous infusion will have to be continued for a prolonged period. Thus, the patient’s ability to accept and to be responsible for an indwelling catheter and infusion device should be carefully considered.
Treprostinil is a potent pulmonary and systemic vasodilator. In subjects presenting with low systemic arterial pressure, treprostinil treatment may increase the risk of systemic hypotension. Treatment is not recommended for patients with systolic arterial pressure of less than 85 mmHg.
It is recommended to monitor systemic blood pressure and heart rate during any change in dose with instructions to stop the infusion if symptoms of hypotension develop, or a systolic blood pressure of 85 mmHg or lower is detected. 2).
If a patient contracts pulmonary oedema while on treprostinil, the possibility of an associated pulmonary veno-occlusive disease should be considered. The treatment should be stopped. Obese patients (BMI greater than 30 kg/m2) clear treprostinil more slowly.
The benefit of treprostinil subcutaneous treatment in patients with more severe pulmonary arterial hypertension (NYHA functional class IV) has not been established. The efficacy/safety ratio of treprostinil has not been studied in pulmonary arterial hypertension associated with left-right cardiac shunt, portal hypertension, or HIV infection.
2). Caution is advised in situations where treprostinil may increase the risk of bleeding by inhibiting platelet aggregation. 75% of the WHO recommended maximum daily intake of 2 g sodium for an adult. g. gemfibrozil) may increase exposure (both Cmax and AUC) to treprostinil.
Increased exposure is likely to increase adverse events associated with treprostinil administration. 5). g. rifampicin) may decrease exposure to treprostinil. Decreased exposure is likely to reduce clinical effectiveness. 5).
• known hypersensitivity to treprostinil or to any of the excipients. • pulmonary arterial hypertension related to veno-occlusive disease. • congestive heart failure due to severe left ventricular dysfunction. • severe liver impairment (Child-Pugh Class C).
• active gastrointestinal ulcer, intracranial hemorrhage, injury or other bleeding condition. • congenital or acquired valvular defects with clinically relevant myocardial dysfunction not related to pulmonary hypertension. g. transient ischemic attack, stroke) within the last three months.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The optimal strategy for reintroducing treprostinil infusion needs to be determined on a case by case basis by medically qualified personnel. In most cases, after an interruption of a few hours, restarting of treprostinil infusion can be done using the same dose rate; interruptions for longer periods may require the dose of treprostinil to be re-titrated.
In Elderly Clinical studies of treprostinil did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. In a population pharmacokinetic (PK) analysis, plasma clearance of treprostinil was reduced by 20%.
In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. Children and adolescents There are few data in patients less than 18 years of age.
Available clinical studies do not establish whether the efficacy and safety of the recommended posology scheme for adults can be extrapolated to children and adolescents. At risk populations Hepatic impairment Plasma treprostinil exposure (area under the plasma concentration-time curve, AUC) increases by 260% to 510% in mild to moderate hepatic impairment, Child-Pugh classes A and B, respectively.
Plasma clearance of treprostinil was reduced up to 80% in subjects presenting with mild to moderate hepatic impairment. Caution is therefore advised when treating patients with hepatic impairment because of the risk of an increase in systemic exposure which may reduce tolerability and lead to an increase in dose-dependent adverse effects.
625 ng/kg/min and incremental dose increases should be made cautiously. Renal impairment No dose adjustments are required in patients with renal impairment. 2)]. Method of transition to intravenous epoprostenol treatment When transition to intravenous epoprostenol is required, the transition phase should be carried out under strict medical supervision.
It may be useful for guidance purposes to note the following suggested treatment transition scheme. 5 ng/kg/min. After at least one hour at the new treprostinil dose, epoprostenol treatment can be initiated at a maximum dose of 2 ng/kg/min.
The treprostinil dose should then be decreased at subsequent intervals of at least 2 hours, and at the same time the epoprostenol dose is gradually increased after maintaining the initial dose for at least one hour. Mode of administration Administration by continuous subcutaneous infusion Treprostinil Tillomed is administered by continuous subcutaneous infusion via a subcutaneous catheter using an ambulatory infusion pump.
In order to avoid potential interruptions in drug delivery, the patient must have access to a backup infusion pump and subcutaneous infusion sets in the event that the administration equipment should suffer an accidental malfunction.
002 ml/h, 3) fitted with occlusion, low battery, programming error […]
There were also reports of haemoptysis, haematemesis and haematuria, but these occurred with the same or lower frequency than in the placebo group. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Adverse Events attributable to the Intravenous Drug Delivery System:
Central venous catheter associated blood stream infections and sepsis have been reported in patients receiving treprostinil by intravenous infusion. These risks are attributable to the drug delivery system. 10 events per 1000 catheter days.
Clinicians should be aware of the range of possible Gram-negative and Gram-positive organisms that may infect patients with long-term central venous catheters, therefore, continuous subcutaneous infusion of undiluted treprostinil is the preferred mode of administration.
2).