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Recormon (5000 IU) Injection(0.3 mL)
Recormon (5000 IU) Injection(0.3 mL)
Treatment of anemia associated with chronic renal failure (renal anemia) in patients on dialysis. Treatment of symptomatic renal anemia in patients not yet undergoing dialysis.
Treatment of anemia in adult patients with solid tumors and treated with platinum-based chemotherapy prone to induce anemia (cisplatin: 75 mg/m2/cycle, carboplatin: 350 mg/m2/cycle).
Treatment of anemia in adult patients with multiple myeloma, low grade non-Hodgkins lymphoma or chronic lymphocytic leukemia, who have a relative erythropoietin deficiency and are receiving anti-tumor therapy. Increasing the yield of autologous blood from patients in a pre-donation program. Its use in this indication must be balanced against the reported increased risk of thromboembolic events. Treatment should only be given to patients with moderate anemia (Hb 10-13 g/dL [6.21-8.07 mmol/L], no iron deficiency) if blood conserving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males).
Deficiency is defined as an inappropriately low serum erythropoietin level in relation to the degree of anemia.
Use only for the condition for which it was prescribed. Do not give this medicine to other people even if they have the same symptoms you have, as it may not be right for them.
Dietary consideration
Recormon in pre-filled syringes contains up to 0.3 mg (500IU-6000IU) or 0.6 mg (10 000 IU and 20 000 IU) phenylalanine/syringe as an excipient. Therefore this should be taken into consideration in patients affected with severe forms of phenylketonuria.
This medicinal product contains less than 1 mmol sodium (23 mg) per syringe, i.e. essentially sodiumfree.
Contraindications
Poorly controllable hypertension and known hypersensitivity to any of the constituents of Recormon.
In increasing the yield of autologous blood, Recormon must not be used in patients who, in the month preceding treatment, have suffered a myocardial infarction or stroke, patients with unstable angina pectoris or patients who are at risk of deep venous thrombosis eg, those with a history of venous thromboembolic disease.
This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
Important safety information
Warnings/Precautions
Recormon should be used with caution in the presence of refractory anemia with excess blasts in transformation, epilepsy, thrombocytosis, and chronic liver failure.
Folic acid and vitamin B12 deficiencies should be ruled out as they reduce the effectiveness of Recormon.
Severe aluminium overload due to treatment of renal failure may compromise the effectiveness of Recormon.
The indication for treatment with Recormon of nephrosclerotic patients not yet undergoing dialysis should be defined individually as a possible acceleration of progression of renal failure cannot be ruled out with certainty.
Patients who have developed anti-erythropoietin antibodies and pure red cell aplasia under treatment with another erythropoietic substance should not be switched to Recormon due to possible cross-reactivity of antibodies to all erythropoietic substances.
In chronic renal failure patients there may be a moderate dose-dependent rise in the platelet count within the normal range during treatment with Recormon, especially after
intravenous administration. This regresses during the course of continued therapy. It is recommended that the platelet count be monitored regularly during the first 8 weeks of therapy.
In cancer patients platelet counts should be monitored at regular intervals during Recormon therapy.
In patients in an autologous blood predonation programme there may be an increase in platelet count, mostly within the normal range. Therefore, it is recommended that the
platelet count be determined at least once a week in these patients. If there is an increase in platelets of more than 150 x 109/l or if platelets rise above the normal range, treatment with Recormon should be discontinued.
In chronic renal failure patients an increase in heparin dose during haemodialysis is frequently required during the course of therapy with Recormon as a result of the increased packed cell volume. Occlusion of the dialysis system is possible if heparinisation is not optimum.
Early shunt revision and thrombosis prophylaxis by administration of acetylsalicylic acid, for example, should be considered in chronic renal failure patients at risk of shunt thrombosis.
Serum potassium levels should be monitored regularly during therapy with Recormon.
Potassium elevation has been reported in a few uremic patients receiving Recormon, though causality has not been established. If an elevated or rising potassium level is observed then consideration should be given to ceasing administration of Recormon until the level has been corrected.
For use of Recormon in an autologous predonation program, the official guidelines on principles of blood donation must be considered, in particular:
- only patients with a PCV equal to or greater than 33% (hemoglobin equal to or greater than 11 g/dL [6.83 mmol/L]) should donate;
- special care should be taken with patients below 50 kg weight;
- the single volume drawn should not exceed approx. 12% of the patients estimated blood volume.
Treatment should be reserved for patients in whom it is considered of particular importance to avoid homologous blood transfusion taking into consideration the
risk/benefit assessment for homologous transfusions.
Misuse by healthy persons may lead to an excessive increase in packed cell volume. This may be associated with life-threatening complications of the cardiovascular system.
Recormon in pre-filled syringes contains up to 0.3 mg (500IU-6000IU) or 0.6 mg (10 000 IU and 20 000 IU) phenylalanine/syringe as an excipient. Therefore this should be taken
into consideration in patients affected with severe forms of phenylketonuria.
Possible side effects
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.
Side effects may include:
Very common (10%)
Not established
Common (1%-10%)
Hypertension, Headache
Local: Clotted vascular access (7%)
Serious ADR (1%)
Uncommon
Hypertensive crisis (in anaemic patients with chronic renal failure)
Rare
Shunt thrombosis, rash, pruritus, urticaria or injection site reactions
Very rare
Thrombocytosis (commom in patient with cancer), treatment-related flu-like symptoms such as fever, chills, headaches, pain in the limbs, malaise and/or bone pain.
Interaction with other medication
It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while having treatment with this one, to ensure that the combination is safe.
Antagonises the hypotensive effects of ACE inhibitors and angiotensin-II receptor antagonists and increases risk of hyperkalaemia.
Source: WebMD
