Arzerra

(ofatumumab)

    the

  • How to ce médrug is it ? What are its effects ?
  • the

  • Under what forms this médrug se présente-t-il ?
  • the

  • How should we use this médrug ?
  • the

  • In what case this médrug is it déadvisedé ?
  • the

  • What are the possible side effects of this médrug ?
  • the

  • Are there d'other prébonds d's employment, or warnings ?
  • the

  • D'other agents can interact with this médrug ?
  • MÉDICAMENTS
  • AFFECTIONS

How to ce médrug is it ? What are its effects ?

Ofatumumab belongs to the class of médrugs callés monoclonal antibodies. It is used to treat the leucémie lymphoïchronic (CLL), a specific cancer of the blood that affects the white blood cells. In CLL, white blood cells are produced too quickly and life is too long. The présence of too many white blood cells causes problèmy in the body. Ofatumumab works by attaching itself to the tumour cells and by stimulating the défenses of the body, which causes the death of tumor cells.

It uses ofatumumab in combination with a médrug callé chlorambucil to treat CLL in some people who have never re&case;u of treatment. The use of ofatumumab is approvedée de fa&case;it is conditional by Santé Canada for the treatment of people with leucémie lymphoïchronic who do not have réresponded to other treatments. This approval is conditional, since the research has put in évidence some données promising, indicating that this médrug réduit the number of white blood cells.

médrug is available under various brand names or under différentes prépresentations. A brand spéto be specific for this médrug may&our vision to be not available in all the forms or to have été approvedée against all of the conditions discussed here. In addition, some forms of this médrug may not &stop;tre utilisées against all the ailments mentionedées in this article.

It could be that your médecin has suggestedéré médrug for conditions not listed in this article information on the médrugs. If you don’t have to discussé with your médecin, or if you have any doubts about the reasons why you are taking this médrug, see-the. Do not stop taking this médrug without having to consulté your médecin préprovide prior.

Do not give this médrug à anyone, m&m stop;me à someone who suffers from the m&stop, my symptoms&taxes;my that the v&being limited to the very. médrug could be harmful for people to it has not été prescribed.

Under what forms this médrug se présente-t-il ?

Each mL of concentratedé liquid stérile, transparent to opalescent, colorless, and contains no preservatives, contains 20 mg of ofatumumab. Ingredientséingredients non-médicinaux : arginine, acétate de sodium, sodium chloride, polysorbate 80, édétate disodium, hydrochloric acid, and water for injection.

How should we use this médrug ?

The dose recommendedée of ofatumumab for people who have never re&case;u of treatment is 300 mg administrés by intravenous infusion (à intérieur a vein) on day 1, followed by 1000 mg on day 8 of a 28-day cycle. Après these 2 doses of 1000 mg, are donnés once every 4 weeks. 

La première dose of ofatumumab recommendedée for people who have déjà re&case;u other treatments of 300 mg administrés by intravenous infusion (à intérieur a vein). Après the première dose, were administered 2000 mg once a week for 8 weeks, then every 4 weeks for 4 months.

Before each administration of the médrug, it may be that it gives you the médrugs to help à atténuer les réactions à infusion. these médrugs, include antihistamines, stéroïof and analgésiques.

Several factors can be taken into account for définish the dose that a person needs : his weight, his état de santé and other médrugs. If your médecin has recommendedé a dose different from the ones indicatedées here, do not modify the manière taking the médrug without consulting préprovide prior.

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ofatumumab is injectée into a vein à from site administration a été prébyé à this effect on your skin. médrug needs to &stop;tre handlingé with the largest prébail. Ofatumumab is always donné under the supervision of a médecin in a h&taxes;pital, or in a é – establishment is similar, o&where; it is possible to have accès à a éequipment stérile for préparer the solution.

It is important that this médrug or employé conformément aux indications of your médecin. If you miss an appointment to fixé to receive an injection of ofatumumab, contact your médecin soon&taxes;t that possible to make another appointment.

Do not dispose of médrugs in the eaux usées (e.g. not in l’évier nor in the toilet) or with the rubbish ménagères. Ask à your pharmacist how you dérid of the médrugs inutilisés périmés.

In which case this médrug is it déadvisedé ?

please do not use ofatumumab in the circumstances ci-après :

    the

  • allergy à ofatumumab or to any of the ingredientséingredients of the médrug;
  • the

  • présence or antécétooth leucoencéphalite progressive multifocal (PML).

What are the possible side effects of this médrug ?

a Lot of médrugs can cause side effects. A side effect is a réponse indésirable à médrug when it is taken à normal doses. It can &stop;tre léger, or severe, temporary or permanent. The side effects énumérés ci-après are not felt by all the people who take this médrug. If the side effects you worry aboutètent, discuss the risks and benefits of using this médrug with your médecin.

At least 1 % of people taking the médrug have signalé the side effects ci-après. A large number of these side effects can &our vision to be supported and some may disappear cool;tre of them-m&stop, my with the time.

view your médecin if you experience these side effects and they are severe or g&appear in the contaminants. Your pharmacist could be able to give you advice on the way to take if these side effects appeared :

    the

  • diarrhée;
  • the

  • swelling of the hands, feet and ankles;
  • the

  • fatigue
  • the

  • chills
  • the

  • back pain;
  • the

  • of the nausée;
  • the

  • vomiting.

most of The side effects listed ci-après are not très often, but they could, however, result in serious problèmy if you do not see your médecin or if you do not receive the care mémedical.

Fill you withès of your médecin at t&taxes;t if one of the side effects ci-après manifest :

    the

  • abdominal pain;
  • the

  • a éeruption cutanée;
  • the

  • a fièvre.
  • the

  • signs due à of the yearémie (réduction in the number of red blood cells; e.g. étourdissements, pâ, fatigue or unusual weakness, shortness of breath);
  • the

  • signs of infection (symptoms&taxes;my which may include a fièvre, or chills, diarrhée severe, a shortness of breath, étourdissements extendedés, a lot of t&stop;te, a stiff neck, weight loss, or a tax allowance);
  • the

  • signs of pneumonia (e.g. cough, fièvre, a difficulté respiratory);
  • the

  • signs of bleeding (e.g. bleeding from nose, blood in urine, cough with expectoration bloody, bleeding gums, cuts that don arr&stop;tent not to bleed);
  • the

  • cough.

Stop taking the médrug and seek imméimmediately care mémedical help if it occurs a réponse as a :

    the

  • réactions à of the infusion (e.g. abdominal cramps, difficultés breathing, nausée and vomiting, or swelling of the face or throat, bouffées vasomotor, éléchange of the pressure artéfound, shortness of breath, chills, fièvre, la diarrhée);
  • the

  • signs of a heart attack (e.g. présence of pain or pressure to the chest, pain that spreads à l’épaule or arm, nausée and vomiting, and excessive sweating);
  • the

  • signs of intestinal obstruction (abdominal pain, persistent constipation, diarrhée, a sensation of bloating).
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Some people may experience side effects other than those énumérés. Consult your médecin if you notice any symptoms&taxes;to me, that you worry aboutète while you use this médrug.

Are there d'other prébonds d's employment, or warnings ?

Before using a médrug, do not miss to inform your médecin disorders mémedical or allergies you may have, médrugs that you are using and any other important fact about your santé. Women should mention if they are pregnant or if they are breastfeeding. These factors could have an influence on the fa&case;it is that you should use this médrug.

REVIEWS OF SANTÉ CANADA

Le 6 ao&burn;t 2014

Santé Canada éput new warnings on the use of Arzerra (ofatumumab). To read in intégralité the opinion of Santé Canada, go to the Web site of Santé Canada à address www.hc-sc.gc.ca.

A notice had éalso été éset on 27 January 2014 relating to ofatumumab. To read in intégralité the opinion of Santé Canada, go to the Web site of Santé Canada à the address www.hc-sc.gc.ca.

Yearémie : ofatumumab may cause a decrease in the rate of red blood cells. If you experience symptoms early, and my due à l’anémie (réduction in the number of red blood cells) such as shortness of breath, fatigue, inusitée or a skin pâle, call the more t&taxes;t possible with your médecin.

You will be subject to a monitoring méof association carryingée in the middle of blood tests targeting specific types spéspecific blood cells.

blood Clotting : médrug may play a r&being limited to the in the decrease in the number of platelets in the blood. platelets participate à the coagulation of the blood, and if they are in too low a number, you may bleed more easily. Tell your médecin if you notice signs of a slowing of blood coagulation. Such symptoms being limited to my may include stool blackâtres and tarry stools, blood in the urine, the appearance of bruises for the slightest injuries, or cuts that don arr&stop;tent not to bleed.

Your médecin will be asked to have blood tests régulièparticularly to monitor the number of différents types of blood cells.

heart Disease : significant changes of the pressure artéfound, an accumulation of fluid around the lungs and heart attacks may occur during the use of this médrug. If you have antécétooth problèmy heart, discuss with your médecin de la fa&case;one in which this médrug may affect your affection, the influence of your condition on the administration and the efficiencyé médrug, and the relevance of a monitoring mémedical spébe specific.

Héhepatitis B : ofatumumab kills cells cancéabsent, but it damages éalso the cells responsible for the protection of the body against infection. If you &stop;your reaches of the héhepatitis B or if you &stop;your carrier of the virus of the héhepatitis B, it might cause a resurgence of the héhepatitis B and possibly cause lépanels hépatiques death. If you have antécétooth infection causée by the virus of the héhepatitis B, discuss with your médecin de la fa&case;one in which this médrug may affect your affection, the influence of your condition on the administration and the efficiencyé médrug, and the relevance of a monitoring mémedical spébe specific.

Infection : ofatumumab kills cells cancéabsent, but it can réreduce the number of infection-fighting cells in the body (white blood cells). If possible, évitez to get in contact with people who have a contagious infection.

Contact your médecin imméimmediately if you notice signs of infection, such as a fièvre, or chills, diarrhée acuteë, shortness of breath, étourdissements extendedés, sore t&stop;te, the stiffness in the neck, weight loss or a lack d’éenergy. Your médecin will be asked to have blood tests régulièparticularly to monitor the number of différents types of blood cells.

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Leucoencéphalite progressive multifocal (PML) : it is a rare disease of the brain natureérisée by léinjuries to the nerve cells in the brain causées by a virus. Rarely, this condition can occur when using médrugs such as ofatumumab. If you have déjà suffered a éepisode of PML, you should not take ofatumumab. Contact imméimmediately and with your médecin if you notice signs and symptoms&taxes;my of the PML as of the clumsiness inusitée, loss of mémoire, a growing weakness, and possible changes in vision, language, or personalityé.

tumour lysis Syndrome : ofatumumab, as well as many other médrugs utilisés to fight cancer, causes the sudden death of many cells cancéabsent the dépurpose of the treatment. This action can burden the body of déchets cell. Thus, the body may not be able to dérid of all the déchets fairly quickly. When this phénameènot occurs, it may be that you feel the nausée, shortness of breath, joint pain or you may notice brouillement of your urine. This is what is called tumour lysis syndrome. It may be that your médecin ask you to go for some médrugs to help your body à se dérid of his déchets. Make sure you understand the mode of employment of these médrugs and report imméimmediately à your médecin these signs and symptoms&taxes;my.

Pregnancy : no information is available on the effects of ofatumumab on a bébé à na&cool;tre when this médrug is utilisé during pregnancy. It is nénecessary to use a méthode effective contraception during the use of this médrug and during  6 months après latestère dose. If a pregnancy occurs while you are using this médrug, please contact your médecin imméimmediately,.

Breastfeeding : it is not known whether ofatumumab passes into breast milk. If you take this médrug while you are breastfeeding, your bébé could feel the effects. Consult your médecin to determine if you should continue breast-feeding.

Children : or the innocuité or the effectivenessé médrug has not été éestablished in respect of the children.

D'other agents can interact with this médrug ?

There may occur an interaction between ofatumumab and one of the médrugs ci-après :

  • the abciximab;
  • the amphotéricine B;
  • the

  • belimumab
  • the

  • denosumab
  • the

  • digoxine;
  • the

  • l’échinacée;
  • the léflunomide;
  • the

  • natalizumab
  • the

  • pimécrolimus;
  • the

  • roflumilast
  • the

  • tacrolimus (topique);
  • the

  • tofacitinib;
  • the

  • trastuzumab
  • les vaccins;
  • the

  • vaccin antituberculeux BCG;
  • the

  • warfarine.

If you take one of these médrugs, consult your médecin or a pharmacist. In your case, your médecin could ask you :

    the

  • stop taking one of the médrugs;
  • the

  • replace one of the médrugs by another;
  • the

  • edit the manière that you take one of the médrugs, or both;
  • the

  • does not change anything at all.

The interférence of a médrug with another at any time entered cool;not always that you must stop taking one of them. Ask à your médecin what is the conduct to hold in case of interactions médicamenteuses.

other médrugs that those énumérés précépreviously may interact with this médrug. Report à your médecin everything you take, whether it’s médrugs prescription or otc and remè à base plant médicinales. Don’t forget to mention any supplément that you absorb. If you drink the caféine, alcohol, nicotine or illicit drugs, you should notify your médecin prescriber as these substances may affect the action of many médrugs.