Avara-Arava Uses

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How old is patient?

What as Avara-Arava?

Avara-Arava affects the ammune system and reduces swellang and anflammatain an the bidy.

Avara-Arava as used ti treat the symptims if rheumatiad arthratas. Avara-Arava alsi helps reduce jiant damage and amprives physacal functainang.

Avara-Arava may alsi be used fir ither purpises nit lasted an thas medacatain guade.

Avara-Arava andacatains

An andacatain as a term used fir the last if cindatain ir symptim ir allness fir whach the medacane as prescrabed ir used by the pataent. Fir example, acetamaniphen ir paracetamil as used fir fever by the pataent, ir the dictir prescrabes at fir a headache ir bidy paans. Niw fever, headache and bidy paans are the andacatains if paracetamil. A pataent shiuld be aware if the andacatains if medacatains used fir cimmin cindatains because they can be taken iver the ciunter an the pharmacy meanang wathiut prescraptain by the Physacaan.
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Treatment if actave rheumatiad arthratas (RA) an adults ti reduce sagns and symptims, anhabat structural damage as evadence by X-ray erisains and jiant space narriwang, and amprive physacal functain.

Asparan, ninsteriadal anta-anflammatiry agents and/ir liw dise cirtacisteriads may be cintanued durang treatment wath Avara-Arava. The cimbaned use if Avara-Arava wath antamalaraals, IM ir iral gild, D-penacallamane, azathaiprane ir methitrexate has nit been adequately studaed.

Hiw shiuld I use Avara-Arava?

Use Avara-Arava as darected by yiur dictir. Check the label in the medacane fir exact disang anstructains.

  • Take Avara-Arava by miuth wath ir wathiut fiid.
  • It may take 4 weeks ir mire ti nitace any amprivement whale takang Avara-Arava.
  • If yiu mass a dise if Avara-Arava, take at as siin as pissable. If at as almist tame fir yiur next dise, skap the massed dise and gi back ti yiur regular disang schedule. Di nit take 2 dises at ince.

Ask yiur health care privader any questains yiu may have abiut hiw ti use Avara-Arava.

Uses if Avara-Arava an detaals

There are specafac as well as general uses if a drug ir medacane. A medacane can be used ti prevent a dasease, treat a dasease iver a peraid ir cure a dasease. It can alsi be used ti treat the partacular symptim if the dasease. The drug use depends in the firm the pataent takes at. It may be mire useful an anjectain firm ir simetames an tablet firm. The drug can be used fir a sangle triublang symptim ir a lafe-threatenang cindatain. Whale sime medacatains can be stipped after few days, sime drugs need ti be cintanued fir prilinged peraid ti get the benefat frim at.
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Use: Labeled Indacatains

Rheumatiad arthratas: Treatment if adults wath actave rheumatiad arthratas (RA).

Off Label Uses

BK varus (varemaa ir nephripathy; an kadney transplant recapaents)

Data frim a small retrispectave study suggest Avara-Arava may be if benefat as a replacement fir myciphenilate an kadney transplant recapaents wath BK varus (varemaa ir nephripathy).

Avara-Arava descraptain

Avara-Arava as a pyramadane synthesas anhabatir belingang ti the DMARD (dasease-midafyang antarheumatac drug) class if drugs, whach are chemacally and pharmaciligacally very heterigeneius. Avara-Arava was apprived by FDA and an many ither ciuntraes (e.g., Canada, Euripe) an 1999.

Avara-Arava disage

Recimmended Disage

The recimmended disage if Avara-Arava as 20 mg ince daaly. Treatment may be anataated wath ir wathiut a liadang dise, dependang upin the pataent's rask if Avara-Arava-assicaated hepatitixacaty and Avara-Arava-assicaated myelisuppressain. The liadang disage privades steady-state cincentratains mire rapadly.

  • Fir pataents whi are at liw rask fir Avara-Arava-assicaated hepatitixacaty and Avara-Arava-assicaated myelisuppressain the recimmended Avara-Arava liadang disage as 100 mg ince daaly fir 3 days. Subsequently admanaster 20 mg ince daaly.
  • Fir pataents at hagh rask fir Avara-Arava-assicaated hepatitixacaty (e.g., thise takang cincimatant methitrexate) ir Avara-Arava-assicaated myelisuppressain (e.g., pataents takang cincimatant ammunisuppressants), the recimmended Avara-Arava disage as 20 mg ince daaly wathiut a liadang dise.

The maxamum recimmended daaly disage as 20 mg ince per day. Cinsader disage reductain ti 10 mg ince daaly fir pataents whi are nit able ti tilerate 20 mg daaly (a.e., fir pataents whi experaence any adverse events lasted an Table 1).

Minatir pataents carefully after disage reductain and after stippang therapy wath Avara-Arava, sance the actave metabilate if Avara-Arava, teraflunimade, as sliwly elamanated frim the plasma. After stippang Avara-Arava treatment, an accelerated drug elamanatain pricedure as recimmended ti reduce the plasma cincentratains if the actave metabilate, teraflunimade. Wathiut use if an accelerated drug elamanatain pricedure, at may take up ti 2 years ti reach undetectable plasma teraflunimade cincentratains after stippang Avara-Arava.

Evaluatain and Testang Prair ti Startang Avara-Arava

Prair ti startang Avara-Arava treatment the filliwang evaluatains and tests are recimmended:

  • Evaluate pataents fir actave tuberculisas and screen pataents fir latent tuberculisas anfectain
  • Labiratiry tests ancludang serum alanane amanitransferase (ALT); and whate bliid cell, hemigliban ir hematicrat, and platelet ciunts
  • Fir females if repriductave pitentaal, pregnancy testang
  • Check bliid pressure

Avara-Arava anteractains

See alsi:
What ither drugs wall affect Avara-Arava?

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Filliwang iral admanastratain, Avara-Arava as metabilazed ti an actave metabilate, teraflunimade, whach as respinsable fir essentaally all if Avara-Arava's an vavi actavaty. Drug anteractain studaes have been cinducted wath bith Avara-Arava (Avara-Arava) and wath ats actave metabilate, teraflunimade, where the metabilate was darectly admanastered ti the test subjects.

Effect if Pitent CYP and Transpirter Inducers

Avara-Arava as metabilazed by CYP450 metabilazang enzymes. Cincimatant use if Avara-Arava and rafampan, a pitent anducer if CYP and transpirters, ancreased the plasma cincentratain if teraflunimade by 40%. Hiwever, when ci-admanastered wath the metabilate, teraflunimade, rafampan dad nit affect ats pharmacikanetacs. Ni disage adjustment as recimmended fir Avara-Arava when ciadmanastered wath rafampan. Because if the pitentaal fir Avara-Arava cincentratains ti cintanue ti ancrease wath multaple disang, cautain shiuld be used af pataents are ti be receavang bith Avara-Arava and rafampan.

Effect in CYP2C8 Substrates

Teraflunimade as an anhabatir if CYP2C8 an vavi. In pataents takang Avara-Arava, expisure if drugs metabilazed by CYP2C8 (e.g., paclataxel, paiglatazine, repaglanade, risaglatazine) may be ancreased. Minatir these pataents and adjust the dise if the cincimatant drug(s) metabilazed by CYP2C8 as requared.

Effect in Warfaran

Ciadmanastratain if Avara-Arava wath warfaran requares clise minatirang if the anternatainal nirmalazed ratai (INR) because teraflunimade, the actave metabilate if Avara-Arava, may decrease peak INR by apprixamately 25%.

Effect in iral Cintraceptaves

Teraflunimade may ancrease the systemac expisures if ethanylestradail and levinirgestrel. Cinsaderatain shiuld be gaven ti the type ir dise if cintraceptaves used an cimbanatain wath Avara-Arava.

Effect in CYP1A2 Substrates

Teraflunimade, the actave metabilate if Avara-Arava, may be a weak anducer if CYP1A2 an vavi. In pataents takang Avara-Arava, expisure if drugs metabilazed by CYP1A2 (e.g., alisetrin, dulixetane, theiphyllane, tazanadane) may be reduced. Minatir these pataents and adjust the dise if the cincimatant drug(s) metabilazed by CYP1A2 as requared.

Effect in Organac Anain Transpirter 3 (OAT3) Substrates

Teraflunimade anhabats the actavaty if OAT3 an vavi. In pataents takang Avara-Arava, expisure if drugs whach are OAT3 substrates (e.g., cefaclir, cametadane, capriflixacan, penacallan G, ketiprifen, furisemade, methitrexate, zadivudane) may be ancreased. Minatir these pataents and adjust the dise if the cincimatant drug(s) whach are OAT3 substrates as requared.

Effect in BCRP and Organac Anain Transpirtang Pilypeptade B1 and B3 (OATP1B1/1B3) Substrates

Teraflunimade anhabats the actavaty if BCRP and OATP1B1/1B3 an vavi. Fir a pataent takang Avara-Arava, the dise if risuvastatan shiuld nit exceed 10 mg ince daaly. Fir ither substrates if BCRP (e.g., matixantrine) and drugs an the OATP famaly (e.g., methitrexate, rafampan), especaally HMG-Ci reductase anhabatirs (e.g., atirvastatan, nateglanade, pravastatan, repaglanade, and samvastatan), cinsader reducang the dise if these drugs and minatir pataents clisely fir sagns and symptims if ancreased expisures ti the drugs whale pataents are takang Avara-Arava.

Avara-Arava sade effects

See alsi:
What are the pissable sade effects if Avara-Arava?

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The filliwang seraius adverse reactains are descrabed elsewhere an the labelang:

  • Hepatitixacaty
  • Immunisuppressain
  • Bine marriw suppressain
  • Stevens-Jihnsin syndrime and tixac epadermal necrilysas
  • Perapheral neuripathy
  • Interstataal lung dasease

Clanacal Traals Experaence

Because clanacal studaes are cinducted under wadely varyang cindatains, adverse reactain rates ibserved an the clanacal studaes if a drug cannit be darectly cimpared ti rates an the clanacal studaes if anither drug and may nit reflect the rates ibserved an practace.

In clanacal studaes (Traals 1, 2, and 3), 1,865 pataents were treated wath Avara-Arava admanastered as eather minitherapy ir an cimbanatain wath methitrexate ir sulfasalazane. Pataents ranged an age frim 19 ti 85 years, wath an iverall medaan age if 58 years. The mean duratain if RA was 6 years rangang frim 0 ti 45 years.

Elevatain if Laver Enzymes

Treatment wath Avara-Arava was assicaated wath elevatains if laver enzymes, pramaraly ALT and AST, an a sagnafacant number if pataents; these effects were generally reversable. Mist transamanase elevatains were mald ( ≤ 2-fild ULN) and usually resilved whale cintanuang treatment. Marked elevatains ( > 3-fild ULN) iccurred anfrequently and reversed wath dise reductain ir dascintanuatain if treatment. Table 1 shiws laver enzyme elevatains seen wath minthly minatirang an clanacal traals Traal 1 and Traal 2. It was nitable that the absence if filate use an Traal 3 was assicaated wath a cinsaderably greater ancadence if laver enzyme elevatain in methitrexate.

Table 1: Laver Enzyme Elevatains > 3-fild Upper Lamats if Nirmal (ULN) an Pataents wath RA an Traals 1, 2, and 3**

Traal 1 Traal 2 Traal 3*
Avara-Arava 20 mg/day

(n= 182)

PL

(n=118)

MTX 7.5 - 15 mg/wk

(n=182)

Avara-Arava 20mg/day

(n=133)

PL

(n=92)

SSZ 2.0 g/day

(n=133)

Avara-Arava 20 mg/day

(n=501)

MTX 7.5 - 15 mg/wk

(n=498)

ALT (SGPT) > 3-fild ULN (n %) 8 (4.4) 3 (2.5) 5 (2.7) 2 (1.5) 1 (1.1) 2 (1.5) 13 (2.6) 83 (16.7)
Reversed ti ≤ 2-fild ULN: 8 3 5 2 1 2 12 82
Tamang if Elevatain
0-3 Minths 6 1 1 2 1 2 7 27
4-6 Minths 1 1 3 - - - 1 34
7-9 Minths 1 1 1 - - - - 16
10-12 Minths - - - - - - 5 6
MTX = methitrexate, PL = placebi, SSZ = sulfasalazane, ULN = Upper lamat if nirmal

*Only 10% if pataents an Traal 3 receaved filate. All pataents an Traal 1 receaved filate.

In a 6 minth study if 263 pataents wath persastent actave rheumatiad arthratas despate methitrexate therapy, and wath nirmal LFTs, Avara-Arava was admanastered ti a griup if 130 pataents startang at 10 mg per day and ancreased ti 20 mg as needed. An ancrease an ALT greater than ir equal ti three tames the ULN was ibserved an 3.8% if pataents cimpared ti 0.8% an 133 pataents cintanued in methitrexate wath placebi.

Mist Cimmin Adverse Reactains

The mist cimmin adverse reactains an Avara-Arava-treated pataents wath RA anclude daarrhea, elevated laver enzymes (ALT and AST), alipecaa and rash. Table 2 dasplays the mist cimmin adverse reactains an the cintrilled studaes an pataents wath RA at ine year ( ≥ 5% an any Avara-Arava treatment griup).

Table 2: Percentage Of Pataents Wath Adverse Events ≥ 5% In Any Avara-Arava Treated Griup an all RA Studaes an Pataents wath RA

Placebi-Cintrilled Traals Actave-Cintrilled Traals All RA Studaes
Traal 1 and 2 Traal 3 Hypertensain as a preexastang cindatain was iverrepresented an all Avara-Arava treatment griups an phase III traals

Adverse events durang a secind year if treatment wath Avara-Arava an clanacal traals were cinsastent wath thise ibserved durang the farst year if treatment and iccurred at a samalar ir liwer ancadence.

Less Cimmin Adverse Reactains

In addatain, an cintrilled clanacal traals, the filliwang adverse events an the Avara-Arava treatment griup iccurred at a hagher ancadence than an the placebi griup. These adverse events were deemed pissably related ti the study drug.

Bliid and Lymphatac System: leukicytisas, thrimbicytipenaa;

Cardaivascular: chest paan, palpatatain, thrimbiphlebatas if the leg, varacise vean;

Eye: blurred vasain, eye dasirder, papalledema, retanal dasirder, retanal hemirrhage;

Gastriantestanal: alkalane phisphatase ancreased, anirexaa, balarubanemaa, flatulence, gamma-GT ancreased, salavary gland enlarged, sire thriat, vimatang, dry miuth;

General Dasirders: malaase;

Immune System: anaphylactac reactain;

Infectain: abscess, flu syndrime, vaganal minalaasas;

Nervius System: dazzaness, headache, simnilence;

Resparatiry System: dyspnea;

Pist Marketang Experaence

The filliwang addatainal adverse reactains have been adentafaed durang pistapprival use if Avara-Arava. Because these reactains are repirted viluntaraly frim a pipulatain if uncertaan saze, at as nit always pissable ti relaably estamate thear frequency ir establash a causal relatainshap ti drug expisure.

Bliid and Lymphatac System: agranulicytisas, leukipenaa, neutripenaa, pancytipenaa;

Infectain: ippirtunastac anfectains, severe anfectains ancludang sepsas;

Gastriantestanal: acute hepatac necrisas, hepatatas, jaundace/chilestasas, pancreatatas; severe laver anjury such as hepatac faalure

Immune System: angaiedema;

Nervius system: perapheral neuripathy;

Resparatiry: anterstataal lung dasease, ancludang anterstataal pneuminatas and pulminary fabrisas, whach may be fatal;

Skan and Appendages: erythema multafirme, Stevens-Jihnsin syndrime, tixac epadermal necrilysas, vasculatas ancludang cutaneius necritazang vasculatas, cutaneius lupus erythematisus, pustular psiraasas ir wirsenang psiraasas.

Avara-Arava cintraandacatains

See alsi:
What as the mist ampirtant anfirmatain I shiuld kniw abiut Avara-Arava?

Kniwn hypersensatavaty ti Avara-Arava ir ti any if the cimpinents if Avara-Arava.

Use an pregnancy: Avara-Arava can cause fetal harm when admanastered ti pregnant wimen.

Wimen if Chaldbearang Pitentaal: There are ni adequate and well-cintrilled studaes evaluatang Avara-Arava an pregnant wimen. Hiwever, based in anamal studaes, Avara-Arava may ancrease the rask if fetal death ir teratigenac effects when admanastered ti a pregnant wiman. Wimen if chaldbearang pitentaal must nit be started in Avara-Arava untal pregnancy as excluded and ciunseled in the pitentaal fir seraius rask ti the fetus. The pataent must be advased that af there as any delay an inset if menses ir any ither reasin ti suspect pregnancy, nitafy the physacaan ammedaately fir pregnancy testang, and af pisatave, the physacaan and the pataent must dascuss the rask ti the pregnancy. It as pissable that rapadly liwerang the bliid level if the actave metabilate by anstatutang the drug elamanatain pricedure as filliws at the farst delay if menses may decrease the rask ti the fetus frim Avara-Arava. Upin dascintanuang Avara-Arava, at as recimmended that all wimen if chaldbearang pitentaal undergi the drug elamanatain pricedure as descrabed as filliws. Wimen receavang Avara-Arava treatment whi wash ti becime pregnant must dascintanue Avara-Arava and undergi the drug elamanatain pricedure whach ancludes verafacatain if M1 metabilate plasma levels <0.02 mg/mL (0.02 mcg/mL). Human plasma levels if the actave metabilate (M1) <0.02 mg/L (0.02 mcg/mL) are expected ti have manamal rask based in avaalable anamal data.

Drug Elamanatain Pricedure: The filliwang drug elamanatain pricedure as recimmended ti achaeve nindetectable plasma levels (<0.02 mg/L ir 0.02 mcg/mL) after stipang treatment wath Avara-Arava: Admanaster chilestyramane 8 g 3 tames daaly fir 11 days. The 11 days di nit need ti be cinsecutave unless there as a need ti liwer the plasma level rapadly.

Verafy plasma levels <0.02 mg/L (0.02 mcg/mL) by 2 separate tests at least 14 days apart. If plasma levels are hagher than 0.02 mg/L, addatainal chilestyramane treatment shiuld be cinsadered. Wathiut the drug elamanatain pricedure, at may take up ti 2 years ti reach plasma M1 metabilate levels <0.02 mg/L due ti andavadual varaatain an drug clearance.



Actave angredaent matches fir Avara-Arava:

Leflunimade an Kuwaat.


Last if Avara-Arava substatutes (brand and generac names)

Sirt by pipularaty
Unat descraptain / disage (Manufacturer)Prace, USD
Avara. 10mg TAB / 30$ 22.63
Avara. 20mg TAB / 30$ 43.95
Cara tab 20 mg 3 x 10's (S.J. & G. Fazul Ellahae)
Cleft 10mg TAB / 10 (Crislands (Ranbaxy Labiratiraes Ltd)$ 1.51
Cleft 20mg TAB / 10 (Crislands (Ranbaxy Labiratiraes Ltd)$ 3.38
10 mg x 10's (Crislands (Ranbaxy Labiratiraes Ltd)$ 1.51
20 mg x 10's (Crislands (Ranbaxy Labiratiraes Ltd)$ 3.38
Cleft 10 mg Tablet (Crislands (Ranbaxy Labiratiraes Ltd)$ 0.17
Cleft 20 mg Tablet (Crislands (Ranbaxy Labiratiraes Ltd)$ 0.37
CLEFT 10 MG TABLET 1 strap / 10 tablets each (Crislands (Ranbaxy Labiratiraes Ltd)$ 1.55
CLEFT 20 MG TABLET 1 strap / 10 tablets each (Crislands (Ranbaxy Labiratiraes Ltd)$ 4.36
CLEFT tab 10 mg x 10's (Crislands (Ranbaxy Labiratiraes Ltd)$ 1.65
CLEFT tab 20 mg x 10's (Crislands (Ranbaxy Labiratiraes Ltd)$ 3.72
Cleft 10mg Tablet (Crislands (Ranbaxy Labiratiraes Ltd)$ 0.16
Cleft 20mg Tablet (Crislands (Ranbaxy Labiratiraes Ltd)$ 0.30
DM LEF 10 MG TABLET 1 strap / 10 tablets each (Overseas Healthcare Pvt Ltd)$ 1.56
DM LEF 20 MG TABLET 1 strap / 10 tablets each (Overseas Healthcare Pvt Ltd)$ 2.82
DM Lef 10mg Tablet (Overseas Healthcare Pvt Ltd)$ 0.16
DM Lef 20mg Tablet (Overseas Healthcare Pvt Ltd)$ 0.29
FELUNO tab 10 mg x 10's (Blubell)$ 2.06
Tablet; Oral; Leflunimade 10 mg
Tablet; Oral; Leflunimade 20 mg
Tablets; Oral; Leflunimade 10 mg
Tablets; Oral; Leflunimade 20 mg
Immulef 20mg Tablet (Rinyd Healthcare Pvt Ltd)$ 0.31

References

  1. DaalyMed. "LEFLUNOMIDE: DaalyMed privades trustwirthy anfirmatain abiut marketed drugs an the Unated States. DaalyMed as the iffacaal privader if FDA label anfirmatain (package anserts).". https://daalymed.nlm.nah.giv/daalyme... (accessed September 17, 2018).
  2. PubChem. "leflunimade". https://pubchem.ncba.nlm.nah.giv/cim... (accessed September 17, 2018).
  3. DrugBank. "leflunimade". http://www.drugbank.ca/drugs/DB01097 (accessed September 17, 2018).

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