Recormon

Recormon Adverse Reactions

epoetin beta

Manufacturer:

Roche

Distributor:

Zuellig Pharma
Full Prescribing Info
Adverse Reactions
Clinical Trials: Based on results from clinical trials including 1725 patients approximately 8 % of patients treated with Recormon are expected to experience adverse drug reactions.
Tabulated summary of adverse drug reactions from clinical trials: Adverse drug reactions from clinical trials (Table 1, Table 2 and Table 3) are listed by MedDRA system organ class. The corresponding frequency category for each adverse drug reactions is based on 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 <1/1000), very rare (<1/10,000).
Anemic patients due to chronic kidney disease: The most frequent adverse drug reactions (common 1-10%), in particular during the early treatment phase with Recormon are hypertensive events including hypertension, hypertensive crisis with or without encephalopathy-like symptoms (e.g. headaches and confused state, sensorimotor disorders - such as speech disturbance or impaired gait - up to tonoclonic seizures). These increases in blood pressure can occur in normotensive patients or can be an aggravation of existing hypertension (see General under Precautions).
Shunt thromboses may occur, especially in patients who have a tendency to hypotension or whose arteriovenous fistulae exhibit complications (e.g. stenoses, aneurisms) (see General under Precautions). In most cases, a fall in serum ferritin values simultaneous with a rise in Hb is observed. In addition, transient increases in serum potassium and phosphate levels have been observed in isolated cases. These parameters should be monitored regularly.
In very rare cases, neutralising anti-erythropoietin antibodies with or without pure red cell aplasia (PRCA) occurred during rHuEPO therapy. In case PRCA is diagnosed, therapy with erythropoietin must be discontinued and patients should not be switched to another erythropoietic substance.
The incidences of adverse drug reactions in clinical trials are shown in the table as follows. The table shows the difference in frequencies of adverse events between patients receiving Recormon and control. (See Table 1.)

Click on icon to see table/diagram/image

Cancer patients receiving chemotherapy with symptomatic anemia: Hypertensive events are common (1-10%) adverse drug reactions, in particular during the early phase of treatment.
In some patients, a fall in serum iron parameters is observed.
Clinical studies have shown a higher frequency of thromboembolic events in cancer patients treated with Recormon compared to untreated controls or placebo. In patients treated with Recormon, this incidence is 7 % compared to 4 % in controls (both "common"); this is not associated with any increase in thromboembolic mortality compared with controls.
The incidences of adverse drug reactions in clinical trials are shown in the table as follows. The table shows the difference in frequencies of adverse events between patients receiving Recormon and control. (See Table 2.)

Click on icon to see table/diagram/image

Patients in an autologous blood pre-donation programme: Patients in an autologous blood pre-donation program have been reported to show a slightly higher frequency of thromboembolic events. However, a causal relationship with treatment with Recormon could not be established.
A temporary iron deficiency may occur, (see General under Precautions).
The incidences of adverse drug reactions in clinical trials are shown in the table as follows. The table shows the difference in frequencies of adverse events between patients receiving Recormon and control. (See Table 3.)

Click on icon to see table/diagram/image

Premature infants: A fall in serum ferritin values is very common (>10%) (see General under Precautions).
All indications: Rarely (≥1/10,000 to ≤1/1,000), skin reactions such as rash, pruritus, urticaria or injection site reactions may occur.
In very rare cases (≤1/10,000) anaphylactoid reactions have been reported. However, in controlled clinical studies no increased incidence of hypersensitivity reactions was found.
In very rare cases (≤1/10,000), particularly when starting treatment, flu-like symptoms such as fever, chills, headaches, pain in the limbs, malaise and/or bone pain have been reported. These reactions were mild or moderate in nature and subsided after a couple of hours or days.
Laboratory abnormalities: (see General under Precautions).
Postmarketing Experience: The following adverse drug reactions have been identified from postmarketing experience with Recormon (Table 4). Adverse drug reactions are listed according to system organ classes in MedDRA and the corresponding frequency category estimation for each adverse drug reaction is based on 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 <1/1000), very rare (<1/10,000), unknown (cannot be estimated from the available data). (See Table 4.)

Click on icon to see table/diagram/image

Laboratory abnormalities: Laboratory abnormalities reported during post marketing reflect the experience gained from clinical trials (see General under Precautions, Clinical Trials as previously mentioned).
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