NEWS - New warnings for adalimumab (Humira) in RA

[Guest guest]

New warnings for adalimumab (Humira) in RA

Rheumawire

Nov 9, 2004

Zosia Chustecka

Abbott Park, IL - New warnings have been added to the prescribing

information for adalimumab (Humira, Abbott) about hypersensitivity

reactions and hematologic events that have been reported during

postmarketing surveillance, as well as a caution about its use in

combination with the interleukin-1 blocker anakinra (Kineret, Amgen).

The new wording is outlined in a letter from the manufacturer to health

professionals [1].

Abbott says it has received " rare " postmarketing reports of anaphylaxis.

In clinical trials, approximately 1% of patients were reported to have

some allergic reaction (including allergic rash, anaphylactoid reaction,

fixed drug reaction, nonspecific drug reaction, and urticaria). " If an

anaphylactic or other serious allergic reaction occurs, administration

of adalimumab should be discontinued immediately and appropriate therapy

instituted. "

The company has also received " infrequent reports " of hematologic

events, including medically significant cytopenia (eg, thrombocytopenia,

leukopenia), although it adds that the causal relationship of these

reports to the drug " remains unclear. " It points out, however, that the

FDA has also received rare reports of pantocytopenia, including aplastic

anemia, with TNF-blocking drugs. " All patients are advised to seek

immediate medical attention if they develop signs and symptoms

suggestive of blood dyscrasias or infection (eg, persistent fever,

bruising, bleeding, pallor) while on Humira, " and discontinuation should

be considered in patients with confirmed significant hematologic

abnormalities.

The caution about use in combination with anakinra applies to all

TNF-blocking agents and was added at the request of the FDA to all

manufacturers of these drugs. It was prompted by reports of serious

infections but no added benefit seen with a combination of anakinra and

another TNF inhibitor used in clinical trials. As a result, the use of a

combination of any TNF inhibitor with the interleukin-1 antagonist is

not recommended.

Source

Abbott letter to health professional. November 5,

2004. Available at:

http://www.fda.gov/medwatch/SAFETY/2004/HUMIRA_dhcp.pdf

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org

[Guest guest]

,

Thank you for posting this. I would not know 1/2 of what I know

without this group. My problem with these reports is that they are

not in plain english. I do not know a hematologic event from a case

of thrombocytopenia, or an anaphylactoid reaction from a case of

urticaria. I get that I have to look for signs of infection

including fever, but that has always been true. In any case, I have

printed the article and take it to my next rheumy appointment for

interpretation.

Jennie

> New warnings for adalimumab (Humira) in RA

>

>

> Rheumawire

> Nov 9, 2004

> Zosia Chustecka

>

> Abbott Park, IL - New warnings have been added to the prescribing

> information for adalimumab (Humira, Abbott) about hypersensitivity

> reactions and hematologic events that have been reported during

> postmarketing surveillance, as well as a caution about its use in

> combination with the interleukin-1 blocker anakinra (Kineret,

Amgen).

> The new wording is outlined in a letter from the manufacturer to

health

> professionals [1].

>

> Abbott says it has received " rare " postmarketing reports of

anaphylaxis.

> In clinical trials, approximately 1% of patients were reported to

have

> some allergic reaction (including allergic rash, anaphylactoid

reaction,

> fixed drug reaction, nonspecific drug reaction, and urticaria). " If

an

> anaphylactic or other serious allergic reaction occurs,

administration

> of adalimumab should be discontinued immediately and appropriate

therapy

> instituted. "

>

> The company has also received " infrequent reports " of hematologic

> events, including medically significant cytopenia (eg,

thrombocytopenia,

> leukopenia), although it adds that the causal relationship of these

> reports to the drug " remains unclear. " It points out, however, that

the

> FDA has also received rare reports of pantocytopenia, including

aplastic

> anemia, with TNF-blocking drugs. " All patients are advised to seek

> immediate medical attention if they develop signs and symptoms

> suggestive of blood dyscrasias or infection (eg, persistent fever,

> bruising, bleeding, pallor) while on Humira, " and discontinuation

should

> be considered in patients with confirmed significant hematologic

> abnormalities.

>

> The caution about use in combination with anakinra applies to all

> TNF-blocking agents and was added at the request of the FDA to all

> manufacturers of these drugs. It was prompted by reports of serious

> infections but no added benefit seen with a combination of anakinra

and

> another TNF inhibitor used in clinical trials. As a result, the use

of a

> combination of any TNF inhibitor with the interleukin-1 antagonist

is

> not recommended.

>

> Source

>

>

> Abbott letter to health professional. November 5,

> 2004. Available at:

>

> http://www.fda.gov/medwatch/SAFETY/2004/HUMIRA_dhcp.pdf

>

>

>

>

> I'll tell you where to go!

>

> Mayo Clinic in Rochester

> http://www.mayoclinic.org/rochester

>

> s Hopkins Medicine

> http://www.hopkinsmedicine.org

[Guest guest]

,

Thank you for posting this. I would not know 1/2 of what I know

without this group. My problem with these reports is that they are

not in plain english. I do not know a hematologic event from a case

of thrombocytopenia, or an anaphylactoid reaction from a case of

urticaria. I get that I have to look for signs of infection

including fever, but that has always been true. In any case, I have

printed the article and take it to my next rheumy appointment for

interpretation.

Jennie

> New warnings for adalimumab (Humira) in RA

>

>

> Rheumawire

> Nov 9, 2004

> Zosia Chustecka

>

> Abbott Park, IL - New warnings have been added to the prescribing

> information for adalimumab (Humira, Abbott) about hypersensitivity

> reactions and hematologic events that have been reported during

> postmarketing surveillance, as well as a caution about its use in

> combination with the interleukin-1 blocker anakinra (Kineret,

Amgen).

> The new wording is outlined in a letter from the manufacturer to

health

> professionals [1].

>

> Abbott says it has received " rare " postmarketing reports of

anaphylaxis.

> In clinical trials, approximately 1% of patients were reported to

have

> some allergic reaction (including allergic rash, anaphylactoid

reaction,

> fixed drug reaction, nonspecific drug reaction, and urticaria). " If

an

> anaphylactic or other serious allergic reaction occurs,

administration

> of adalimumab should be discontinued immediately and appropriate

therapy

> instituted. "

>

> The company has also received " infrequent reports " of hematologic

> events, including medically significant cytopenia (eg,

thrombocytopenia,

> leukopenia), although it adds that the causal relationship of these

> reports to the drug " remains unclear. " It points out, however, that

the

> FDA has also received rare reports of pantocytopenia, including

aplastic

> anemia, with TNF-blocking drugs. " All patients are advised to seek

> immediate medical attention if they develop signs and symptoms

> suggestive of blood dyscrasias or infection (eg, persistent fever,

> bruising, bleeding, pallor) while on Humira, " and discontinuation

should

> be considered in patients with confirmed significant hematologic

> abnormalities.

>

> The caution about use in combination with anakinra applies to all

> TNF-blocking agents and was added at the request of the FDA to all

> manufacturers of these drugs. It was prompted by reports of serious

> infections but no added benefit seen with a combination of anakinra

and

> another TNF inhibitor used in clinical trials. As a result, the use

of a

> combination of any TNF inhibitor with the interleukin-1 antagonist

is

> not recommended.

>

> Source

>

>

> Abbott letter to health professional. November 5,

> 2004. Available at:

>

> http://www.fda.gov/medwatch/SAFETY/2004/HUMIRA_dhcp.pdf

>

>

>

>

> I'll tell you where to go!

>

> Mayo Clinic in Rochester

> http://www.mayoclinic.org/rochester

>

> s Hopkins Medicine

> http://www.hopkinsmedicine.org